Long-Term Follow-Up Data Continue to Support Beti-Cel as a Potentially Curative Gene Therapy for β-Thalassemia Patients Who Require Regular Transfusions Through Achievement of Durable Transfusion Independence and Normal or Near-Normal Adult Hb Levels




Long-Term Follow-Up Data Continue to Support Beti-Cel as a Potentially Curative Gene Therapy for β-Thalassemia Patients Who Require Regular Transfusions Through Achievement of Durable Transfusion Independence and Normal or Near-Normal Adult Hb Levels

Treatment effects sustained through long-term follow-up of beyond 10 years in the earliest treated patients (n=2); 81% of participants have >5 years of follow-up

SOMERVILLE, Mass.–(BUSINESS WIRE)–bluebird bio, Inc. (Nasdaq: BLUE) today announced updated data from patients with beta-thalassemia who require regular blood transfusions treated with betibeglogene autotemcel (beti-cel, approved commercially as ZYNTEGLO™) in clinical studies. The data was presented today at the 66^th American Society of Hematology (ASH) Annual Meeting and Exposition.

“Updated follow-up data of up to 10 years showed that patients treated with beti-cel in clinical trials experienced durable transfusion independence and normal or near-normal hemoglobin, regardless of genotype and age, and a continued favorable safety profile”, said Richard Colvin, M.D., Ph.D., chief medical officer, bluebird bio. “We are deeply grateful for the ongoing commitment of our investigators, patients, and study participants. Our collective efforts are not only advancing the field of gene therapy but also providing new hope and possibilities for individuals with severe genetic diseases.”

“Data at ASH demonstrate the durability of beti-cel through 10 years of long-term follow-up, giving additional confidence in that the transformational outcomes observed in parent studies are sustained over time,” said Alexis Thompson, MD, MPH, Chief of the Division of Hematology at Children’s Hospital of Philadelphia, which is a Qualified Treatment Center for ZYNTEGLO. “These long-term data demonstrate beti-cel’s continued positive impact on iron management outcomes over time, which can help inform treatment decisions by clinicians who are now using this therapy in the real-world setting.”

Betibeglogene Autotemcel (beti-cel) Gene Addition Therapy results in durable Hemoglobin A (HbA) Production with up to 10 Years of Follow-Up in Participants with Transfusion-Dependent β-Thalassemia (Poster #2194)

Long-term outcomes with beti-cel in adult and pediatric patients with TDT were presented in a poster session. The data focused on 63 adult and pediatric study participants who had received beti-cel in a Phase 1/2 or Phase 3 study. Two participants had 10 years of follow-up, and 51 (81.0%) participants had 5 or more years of follow-up. Additionally, iron status was assessed in study participants who achieved TI and discontinued chelation therapy. Results showed that majority of participants treated with beti-cel achieved TI. All participants achieved platelet and neutrophil engraftment. Specific findings showed:

• Of 63 patients, 52 (90.2% in Phase 3 studies and 68.2% in Phase 1/2 studies) achieved TI. All except one patient maintained TI through last follow-up. The median weighted average hemoglobin during TI was 10.2 mg/dL for Phase 1/2 studies and 11.2 mg/dL for Phase 3 studies. Achievement and maintenance of TI and median weighted average hemoglobin were similar across ages and genotypes.

• Study participants treated with beti-cel who achieved and maintained TI demonstrated effective restoration of iron homeostasis over time and reduced iron management burden. Among participants who achieved TI, improvements in serum ferritin and liver iron concentration were sustained through month 60. 28/37 (75.7%) study participants who achieved TI in Phase 3 studies are no longer undergoing iron chelation therapy.

• Both adult and pediatric health-related quality of life scores (HRQoL) remained above the normative population mean up to 60 months. All 26 participants who achieved TI and completed a questionnaire reported an overall benefit with beti-cel.

• The safety profile was consistent with known side effects of hematopoietic stem cell collection and the busulfan conditioning regimen. None of the study participants had a fatal event. No beti-cel–related serious adverse events were reported more than 2 years after infusion through last follow-up. No malignancies, insertional oncogenesis or vector-derived replication-competent lentivirus were reported in any study participants.

Beti-cel was approved by the FDA in August 2022 and is commercially available in the United States as ZYNTEGLO.

About ZYNTEGLO® (betibeglogene autotemcel) or beti-cel

ZYNTEGLO is a first-in-class, one-time ex-vivo LVV gene therapy approved for the treatment of beta-thalassemia in adult and pediatric patients who require regular red blood cell transfusions. ZYNTEGLO works by adding functional copies of a modified form of the beta-globin gene (β^A-T87Q-globin gene) into a patient’s own hematopoietic (blood) stem and progenitor cells to enable the production of a modified functional adult hemoglobin (HbA^T87Q). Once a patient has the β^A-T87Q-globin gene, they have the potential to increase ZYNTEGLO-derived adult hemoglobin (HbA^T87Q) and total hemoglobin to normal or near normal levels that can eliminate the need for regular red blood cell (RBC) transfusions.

Indication

ZYNTEGLO is indicated for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions.

Important Safety Information

Delayed Platelet Engraftment

Delayed platelet engraftment has been observed with ZYNTEGLO treatment. Bleeding risk is increased prior to platelet engraftment and may continue after engraftment in patients with prolonged thrombocytopenia; 15% of patients had ≥ Grade 3 decreased platelets on or after Day 100.

Patients should be made aware of the risk of bleeding until platelet recovery has been achieved. Monitor patients for thrombocytopenia and bleeding according to standard guidelines. Conduct frequent platelet counts until platelet engraftment and platelet recovery are achieved. Perform blood cell count determination and other appropriate testing whenever clinical symptoms suggestive of bleeding arise.

Risk of Neutrophil Engraftment Failure

There is a potential risk of neutrophil engraftment failure after treatment with ZYNTEGLO. Neutrophil engraftment failure is defined as failure to achieve three consecutive absolute neutrophil counts (ANC) ≥ 500 cells/microliter obtained on different days by Day 43 after infusion of ZYNTEGLO. Monitor neutrophil counts until engraftment has been achieved. If neutrophil engraftment failure occurs in a patient treated with ZYNTEGLO, provide rescue treatment with the back-up collection of CD34+ cells.

Risk of Insertional Oncogenesis

There is a potential risk of LVV mediated insertional oncogenesis after treatment with ZYNTEGLO.

Patients treated with ZYNTEGLO may develop hematologic malignancies and should be monitored lifelong. Monitor for hematologic malignancies with a complete blood count (with differential) at Month 6 and Month 12 and then at least annually for at least 15 years after treatment with ZYNTEGLO, and integration site analysis at Months 6, 12, and as warranted.

In the event that a malignancy occurs, contact bluebird bio at 1 833-999-6378 for reporting and to obtain instructions on collection of samples for testing.

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of ZYNTEGLO. The dimethyl sulfoxide (DMSO) in ZYNTEGLO may cause hypersensitivity reactions, including anaphylaxis.

Anti-retroviral and Hydroxyurea Use

Patients should not take prophylactic HIV anti-retroviral medications or hydroxyurea for at least one month prior to mobilization, or for the expected duration for elimination of the medications, and until all cycles of apheresis are completed. If a patient requires anti-retrovirals for HIV prophylaxis, then confirm a negative test for HIV before beginning mobilization and apheresis of CD34+ cells.

Interference with Serology Testing

Patients who have received ZYNTEGLO are likely to test positive by polymerase chain reaction (PCR) assays for HIV due to integrated BB305 LVV proviral DNA, resulting in a false-positive test for HIV. Therefore, patients who have received ZYNTEGLO should not be screened for HIV infection using a PCR‑based assay.

Adverse Reactions

The most common non-laboratory adverse reactions (≥20%) were mucositis, febrile neutropenia, vomiting, pyrexia, alopecia, epistaxis, abdominal pain, musculoskeletal pain, cough, headache, diarrhea, rash, constipation, nausea, decreased appetite, pigmentation disorder, and pruritus. The most common Grade 3 or 4 laboratory abnormalities (>50%) include neutropenia, thrombocytopenia, leukopenia, anemia, and lymphopenia.

Drug Interactions

Drug-drug interactions between iron chelators and the myeloablative conditioning agent must be considered. Iron chelators should be discontinued at least 7 days prior to initiation of conditioning. The prescribing information for the iron chelator(s) and the myeloablative conditioning agent should be consulted for the recommendations regarding co-administration with CYP3A substrates.

Some iron chelators are myelosuppressive. After ZYNTEGLO infusion, avoid use of these iron chelators for 6 months. If iron chelation is needed, consider administration of non-myelosuppressive iron chelators. Phlebotomy can be used in lieu of iron chelation, when appropriate.

Pregnancy/Lactation

Advise patients of the risks associated with conditioning agents, including on pregnancy and fertility. ZYNTEGLO should not be administered to women who are pregnant, and pregnancy after ZYNTEGLO infusion should be discussed with the treating physician.

ZYNTEGLO is not recommended for women who are breastfeeding, and breastfeeding after ZYNTEGLO infusion should be discussed with the treating physician.

Females and Males of Reproductive Potential

A negative serum pregnancy test must be confirmed prior to the start of mobilization and re-confirmed prior to conditioning procedures and before ZYNTEGLO administration.

Women of childbearing potential and men capable of fathering a child should use an effective method of contraception (intra uterine device or combination of hormonal and barrier contraception) from start of mobilization through at least 6 months after administration of ZYNTEGLO.

Advise patients of the option to cryopreserve semen or ova before treatment if appropriate.

Please see full Prescribing Information for ZYNTEGLO.

About bluebird bio, Inc.

bluebird bio is pursuing curative gene therapies to give patients and their families more bluebird days.

Founded in 2010, bluebird has been setting the standard for gene therapy for more than a decade—first as a scientific pioneer and now as a commercial leader. bluebird has an unrivaled track record in bringing the promise of gene therapy out of clinical studies and into the real-world setting, having secured FDA approvals for three therapies in under two years. Today, we are proving and scaling the commercial model for gene therapy and delivering innovative solutions for access to patients, providers, and payers.

With a dedicated focus on severe genetic diseases, bluebird has the largest and deepest ex-vivo gene therapy data set in the field, with industry-leading programs for sickle cell disease, β-thalassemia and cerebral adrenoleukodystrophy. We custom design each of our therapies to address the underlying cause of disease and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward.

bluebird continues to forge new paths as a standalone commercial gene therapy company, combining our real-world experience with a deep commitment to patient communities and a people-centric culture that attracts and grows a diverse flock of dedicated birds.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements, such as statements regarding the therapeutic potential of ZYNTEGLO. Such forward-looking statements are based on historical performance and current expectations and projections about bluebird’s future goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond bluebird’s control and could cause bluebird’s future goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect bluebird bio’s business, particularly those identified in the risk factors discussion in bluebird bio’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by its subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC. These risks and uncertainties include, but are not limited to: the risk that the efficacy and safety results from bluebird’s prior and ongoing clinical trials will not continue or be seen in the commercial context; the risk that there is not sufficient patient demand or payer reimbursement to support continued commercialization of ZYNTEGLO; the risk of insertional oncogenic or other safety events associated with lentiviral vector, drug product, or myeloablation, including the risk of hematologic malignancy; and the risk that bluebird’s products, including ZYNTEGLO, will not be successfully commercialized. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, bluebird bio undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

Contacts

Investors:
Courtney O’Leary, 978-621-7347

coleary@bluebirdbio.com

Media:
Jess Rowlands, 857-299-6103

jess.rowlands@bluebirdbio.com

Incyte Announces Positive Results from Phase 3 Trial Evaluating Retifanlimab (Zynyz®) in Combination with Platinum-Based Chemotherapy in Patients with Non-Small Cell Lung Cancer




Incyte Announces Positive Results from Phase 3 Trial Evaluating Retifanlimab (Zynyz®) in Combination with Platinum-Based Chemotherapy in Patients with Non-Small Cell Lung Cancer

— Phase 3 POD1UM-304 trial met primary endpoint of overall survival (OS) and all secondary endpoints in patients with previously untreated metastatic non-small cell lung cancer (NSCLC)

— Data presented at the European Society for Medical Oncology (ESMO) Asia Congress 2024 support the planned 2025 filing of a supplemental Biologics License Application (sBLA) in the U.S. for retifanlimab in NSCLC

WILMINGTON, Del.–(BUSINESS WIRE)–$INCY–Incyte (Nasdaq:INCY) today announced results from the Phase 3 POD1UM-304 trial of retifanlimab (Zynyz^®), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with platinum-based chemotherapy for the treatment of adults with previously untreated non-squamous and squamous metastatic non-small cell lung cancer (NSCLC) not harboring a driver mutation. These data were featured today in a mini oral presentation at the European Society for Medical Oncology (ESMO) Asia Congress 2024, held in Singapore and virtually.

The POD1UM-304 trial results show a clinically meaningful and statistically significant improvement over chemotherapy alone. Patients in the retifanlimab and chemotherapy combination treatment group achieved a median overall survival (OS) of 18.1 months compared to 13.4 months in the placebo and chemotherapy combination group (Hazard Ratio [HR]: 0.75; 95% Confidence Interval [CI] (0.60, 0.93); P=0.0042).

“The positive POD1UM-304 trial results provide additional proof of retifanlimab’s safety and efficacy profile in solid tumors,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “We look forward to leveraging these results to advance our pipeline, particularly in hard-to-treat cancers like NSCLC, and to submitting a supplemental Biologic License Application for this indication to the U.S. Food and Drug Administration next year.”

The trial also met secondary endpoints, including:

• Patients who received retifanlimab in combination with chemotherapy had a 2-month improvement in median progression-free survival (PFS) compared to the placebo and chemotherapy combination group (7.7 vs 5.5 months; [HR: 0.64; 95% CI (0.52, 0.79); P<0.0001]).
• Overall response rate (ORR) and duration of response (DOR) by Blinded Independent Central Review (BICR) each showed improvement in the retifanlimab and chemotherapy combination treatment group versus the placebo and chemotherapy combination group (ORR of 52% [95% CI (47, 57) vs. 39% (95% CI 32, 46), respectively; P=0.0012]; DOR of 12.7 months [95% CI (9.4, 15.2) vs. 6.1 months and [95% CI (4.2, 8.3), respectively]).

Retifanlimab was generally well-tolerated and no new safety issues were identified. The most common treatment-emergent adverse events (TEAEs), in >10% of patients in the retifanlimab and chemotherapy combination treatment group, were anemia (62.7%), decreased appetite (22.6%) and decreased neutrophil count (22.1%). Chemotherapy administration was not compromised by the addition of retifanlimab.

“Lung cancer is the leading cause of cancer deaths globally, with the high majority of cases being NSCLC,” said Shun Lu, M.D., Ph.D., Shanghai Chest Hospital. “I am encouraged by the observed safety and efficacy profile of retifanlimab when added to platinum-based chemotherapy in this patient population and believe the positive results from the POD1UM-304 trial support retifanlimab in combination with chemotherapy as an additional treatment option for previously untreated metastatic NSCLC.”

About Non-Small Cell Lung Cancer

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85% of all lung cancer cases worldwide.¹ It is characterized by the uncontrolled growth of malignant cells in the lungs and is often diagnosed at an advanced stage, making it a leading cause of cancer-related mortality globally.^{1, 2, 3}

About POD1UM

The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-304 in non-small cell lung cancer (NSCLC) and POD1UM-303 in squamous cell anal carcinoma (SCAC), as well as other Phase 1 and 2 studies for patients with solid tumors, including registration-directed trials evaluating retifanlimab as a monotherapy for patients with Merkel cell carcinoma and microsatellite instability-high endometrial cancer.

About POD1UM-304

POD1UM-304 is a Phase 3, global, multicenter, randomized, double-blind study evaluating platinum-based chemotherapy with retifanlimab or placebo in patients with first-line, metastatic squamous or non-squamous NSCLC.

During the study, patients were randomized to receive retifanlimab or placebo intravenously in combination with pemetrexed and carboplatin/cisplatin for non-squamous NSCLC, and with paclitaxel and carboplatin for squamous NSCLC. The primary endpoint is overall survival (OS), and secondary endpoints include progression-free survival (PFS), overall response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (BICR). After verified progressive disease by BICR, patients assigned to the placebo and chemotherapy combination group had the option to cross over to open-label retifanlimab monotherapy.

For more information about the study, please visit https://clinicaltrials.gov/study/NCT04205812.

About Zynyz^® (retifanlimab-dlwr)

Zynyz^® (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

In Europe, Zynyz is approved as a monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy.

Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a registered trademark of Incyte.

Important Safety Information

What is the most important information I should know about ZYNYZ?

ZYNYZ is a medicine that may treat a certain type of skin cancer by working with your immune system. ZYNYZ can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, chest pain

Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdomen) pain or tenderness

Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal

Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, loss of appetite

Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with ZYNYZ. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:

• chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising

Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain

Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Complications, including graft-versus-host disease, in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with ZYNYZ. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with ZYNYZ. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with ZYNYZ if you have severe side effects.

Before you receive ZYNYZ, tell your healthcare provider about all of your medical conditions, including if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. ZYNYZ can harm your unborn baby.
  
  Females who are able to become pregnant:
  
  — Your healthcare provider should do a pregnancy test before you start treatment with ZYNYZ.
  
  — You should use an effective method of birth control during your treatment and for 4 months after your last dose of ZYNYZ. Talk to your healthcare provider about birth control methods that you can use during this time.
  
  — Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with ZYNYZ.
• are breastfeeding or plan to breastfeed. It is not known if ZYNYZ passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of ZYNYZ.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of ZYNYZ include tiredness, muscle and bone pain, itching, diarrhea, rash, fever, nausea.

These are not all the possible side effects of ZYNYZ. Call your doctor for medical advice about side effects.

General information about the safe and effective use of ZYNYZ.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about ZYNYZ, talk with your healthcare provider. You can ask your healthcare provider for information about ZYNYZ that is written for health professionals.

You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Incyte Corporation at 1-855-463-3463.

Please see the full Prescribing Information for ZYNYZ for additional Important Safety Information.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

Incyte Forward-looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s Phase 3 POD1UM-304 trial of retifanlimab (Zynyz), the potential presented by retifanlimab, whether or when retifanlimab, alone or in combination, will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions, and Incyte’s goal of improving the lives of patients, contain predictions, estimates, and other forward-looking statements.

These forward-looking statements are based on our current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and regulatory agencies outside of the United States; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended September 30, 2024. We disclaim any intent or obligation to update these forward-looking statements.

¹ Duma N, et al. Mayo Clin Proc. 2019;94:1623-1640.

² Yang SR, et al. Front Oncol. 2022;12.

³ Alexander M, et al. Lung. 2020;198:897-907.

Contacts

Incyte Contacts:


Media
media@incyte.com

Investors
ir@incyte.com

Janux Therapeutics Announces Closing of Underwritten Public Offering of Common Stock and Pre-Funded Warrants Including Full Exercise of Underwriters’ Option to Purchase Additional Shares for Total Gross Proceeds of $402.5 Million




Janux Therapeutics Announces Closing of Underwritten Public Offering of Common Stock and Pre-Funded Warrants Including Full Exercise of Underwriters’ Option to Purchase Additional Shares for Total Gross Proceeds of $402.5 Million

SAN DIEGO–(BUSINESS WIRE)–$JANX–Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today announced the closing of its previously announced underwritten public offering of 6,150,793 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase up to 833,333 additional shares of common stock, at a public offering price of $63.00 per share and pre-funded warrants to purchase 238,095 shares of common stock at a price of $62.999 per pre-funded warrant, which represents the per share price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The aggregate gross proceeds to Janux from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses and excluding the exercise of any pre-funded warrants, were approximately $402.5 million.

BofA Securities, TD Cowen, Stifel, Cantor and William Blair acted as joint book-running managers for the offering. Wedbush PacGrow, LifeSci Capital, BTIG and Jones acted as co-managers for the offering.

The Company intends to use the net proceeds from the offering to advance clinical development of its internal product pipeline and for general corporate purposes.

The securities were offered by the company pursuant to a Registration Statement on Form S-3 filed with the Securities and Exchange Commission (SEC) that became automatically effective upon filing. A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at dg.prospectus_requests@bofa.com; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, by telephone at (855) 495-9846 or by email at TD.ECM_Prospectus@tdsecurities.com; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at (415) 364-2720, or by email at syndprospectus@stifel.com; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at prospectus@cantor.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, by telephone at (800) 621-0687 or by email at prospectus@williamblair.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Janux Therapeutics, Inc.

Janux is a clinical-stage biopharmaceutical company developing tumor-activated immunotherapies for cancer. Janux’s proprietary technology enabled the development of two distinct bispecific platforms: TRACTr and TRACIr. The goal of both platforms is to provide cancer patients with safe and effective therapeutics that direct and guide their immune system to eradicate tumors while minimizing safety concerns. Janux is currently developing a broad pipeline of TRACTr and TRACIr therapeutics directed at several targets to treat solid tumors. Janux has two TRACTr therapeutic candidates in clinical trials, the first targeting PSMA is in development for prostate cancer, and the second targeting EGFR is being developed for colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the anticipated use of proceeds from the public offering. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Janux’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with market conditions, the satisfaction of customary closing conditions related to the public offering, and the other risks described in Janux’s filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Janux undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contacts

Investors:

Andy Meyer

Janux Therapeutics

ameyer@januxrx.com
(202) 215-2579

Media:

Jessica Yingling, Ph.D.

Little Dog Communications Inc.

jessica@litldog.com
(858) 344-8091

Enanta Pharmaceuticals to Present Topline Results from First-in-Pediatrics Phase 2 Study Evaluating Zelicapavir for Respiratory Syncytial Virus (RSV)




Enanta Pharmaceuticals to Present Topline Results from First-in-Pediatrics Phase 2 Study Evaluating Zelicapavir for Respiratory Syncytial Virus (RSV)

• Conference call and webcast to discuss data on Monday, December 9 at 8:30 a.m. ET

WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for virology and immunology indications, today announced the company will hold a conference call and webcast on Monday, December 9 at 8:30 a.m. ET to share topline results from RSVPEDs, a first-in-pediatrics Phase 2 study evaluating zelicapavir in hospitalized and non-hospitalized children aged 28 days to 36 months with respiratory syncytial virus (RSV).

Conference Call and Webcast Information

The live webcast on Monday, December 9 at 8:30 a.m. ET can be accessed at “Events & Presentations” in the investors section of Enanta’s website. To participate by phone, please register for the call here. It is recommended that participants register a minimum of 15 minutes before the call. Once registered, participants will receive an email with the dial-in information. The archived webcast will be available on Enanta’s website for approximately 30 days following the event.

About Zelicapavir

Zelicapavir, Enanta’s lead N-protein inhibitor, is being developed for the treatment of RSV infection, and has been granted Fast Track designation by the U.S. Food and Drug Administration. Zelicapavir is a nanomolar inhibitor of both RSV-A and RSV-B activity. Zelicapavir is differentiated from RSV fusion inhibitors as the N-protein inhibitor targets the virus’ replication machinery and has demonstrated a high barrier to resistance in vitro. In preclinical studies, zelicapavir maintained antiviral potency across all clinical isolates tested and was active against viral variants resistant to other mechanisms. Zelicapavir demonstrated a favorable safety, pharmacokinetic and drug-drug interaction profile in an extensive Phase 1 program. In a Phase 2 challenge study, zelicapavir achieved highly statistically significant (p<0.001) reductions in RSV viral load and clinical symptoms compared to placebo and was safe and well-tolerated, with infrequent adverse events. Zelicapavir is currently being evaluated in RSVHR, a Phase 2b study in the elderly and/or those with congestive heart failure, chronic obstructive pulmonary disease (COPD) or asthma.

About Respiratory Syncytial Virus

RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under one year of age in the United States and a significant cause of respiratory illness in older adults and immunocompromised individuals.¹ According to the Centers for Disease Control and Prevention, virtually all children in the United States get an RSV infection by the time they are two years old and one to two out of every 100 children younger than six months of age with an RSV infection may need to be hospitalized.² Globally, there are an estimated 33 million cases of RSV annually in children less than five years of age, with about 3 million hospitalized and up to approximately 100,000 dying each year from complications associated with the infection.³ RSV represents a significant health threat for adults older than 65 years of age, with an estimated 177,000 hospitalizations and 14,000 deaths associated with RSV infections annually in the United States.⁴

About Enanta Pharmaceuticals, Inc.

Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta’s clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT and STAT6 inhibition.

Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic hepatitis c virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET^® (U.S.) and MAVIRET^® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations. Please visit www.enanta.com for more information.

Forward Looking Statements Disclaimer

This press release contains forward-looking statements, including with respect to the prospects for further development and advancement of zelicapavir for the treatment of RSV. Statements that are not historical facts are based on management’s current expectations, estimates, forecasts and projections about Enanta’s business and the industry in which it operates and management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the development risks of early stage discovery efforts in the disease areas in Enanta’s research and development pipeline, such as RSV; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV; Enanta’s limited clinical development experience; Enanta’s need to attract and retain senior management and key scientific personnel; Enanta’s need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in “Risk Factors” in Enanta’s most recent Annual Report on Form 10-K for the fiscal year ended September 30, 2024 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. All forward-looking statements contained in this release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Enanta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

1. Centers for Disease Control & Prevention – Respiratory Syncytial Virus Last accessed: December 2024.
2. Centers for Disease Control & Prevention – RSV in Infants and Young Children Last accessed: December 2024.
3. Shi, Ting et al. “Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study.” Lancet (London, England) vol. 390,10098 (2017): 946-958. doi:10.1016/S0140-6736(17)30938-8
4. Falsey, Ann R et al. “Respiratory syncytial virus infection in elderly and high-risk adults.” The New England Journal of Medicine vol. 352,17 (2005): 1749-59. doi:10.1056/NEJMoa043951

Contacts

Media and Investors Contact:
Jennifer Viera

617-744-3848

jviera@enanta.com

Positive CHMP Opinion for the Extension of Indication of Palforzia® for the Treatment of Toddlers With Confirmed Peanut Allergy




Positive CHMP Opinion for the Extension of Indication of Palforzia® for the Treatment of Toddlers With Confirmed Peanut Allergy

BAAR, Switzerland–(BUSINESS WIRE)–#allergyimmunotherapy–Stallergenes Greer, a biopharmaceutical company specialising in allergen immunotherapy (AIT), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion for the extension of the existing indication for Palforzia® (defatted powder of Arachis hypogaea L., semen (peanuts)) to the treatment of toddlers (ages 1 to 3) with a confirmed diagnosis of peanut allergy. If the extension indication is granted by the European Commission, Palforzia® will become the first EMA approved oral immunotherapy (OIT) treatment for toddlers living with confirmed peanut allergy.

Palforzia® is designed to gradually increase the body’s ability to tolerate small amounts of peanut (desensitisation) through carefully controlled and supervised initial dose escalation, up-dosing and maintenance. The extension of the indication, with adjustment of contraindications, would enable treatment to be initiated at an earlier age, thus offering young children and their families the opportunity to reduce the risk of severe allergic reactions from accidental exposure to peanut allergens.¹

The CHMP recommendation is under review by the European Commission which is responsible for the grant of central marketing authorisations in the European Union. If granted, the marketing authorisation would cover all 27 European member states and the three European Economic Area states (Iceland, Liechtenstein and Norway). In July 2024, the U.S. Food and Drug Administration (FDA) approved the extension indication of Palforzia® for use in toddlers.

The regulatory submission is based on data from the Phase 3 POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) study that was published in the New England Journal of Medicine Evidence in 2023. The study evaluated the efficacy and safety of Palforzia® in peanut-allergic children aged 1 to 3 years old, meeting all its primary and secondary efficacy endpoints and demonstrating a favourable safety profile.²

“The positive recommendation of Palforzia® marks a significant step forward for younger children with peanut allergy, as well as for their families. This milestone builds on Stallergenes Greer’s long-standing commitment to delivering innovative solutions for the benefit of allergy sufferers,” says Elena Rizova, Chief Medical Officer, Stallergenes Greer.

As Stallergenes Greer advances efforts to broaden access to Palforzia®, the company remains committed to offering solutions tailored to patient needs. With a comprehensive portfolio which includes oral immunotherapy for food allergy, tablet and liquid sublingual solutions, and subcutaneous formulations for respiratory and insect venom allergies, Stallergenes Greer is paving the way for personalised, precision-based allergen immunotherapy.

ABOUT PALFORZIA®

Palforzia® is indicated by the European Medicine Agency (EMA) in the European Union, by the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., and by Swissmedic in Switzerland for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. Palforzia® may be continued in patients 18 years of age and older. Palforzia® should be used in conjunction with a peanut-avoidant diet.

Palforzia® is also approved by the U.S. Food and Drug Administration (FDA) for ages 1-17 years for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. The treatment is approved for use in patients with a confirmed diagnosis of peanut allergy; Initial Dose Escalation may be administered to patients aged 1 through 17 years. Up-Dosing and Maintenance may be continued in patients 1 year of age and older. Palforzia is to be used in conjunction with a peanut-avoidant diet. Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

Stallergenes Greer acquired the rights to Palforzia^® in September 2023.

ABOUT POSEIDON PHASE 3 STUDY

POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, clinicaltrials.gov number NCT03736447) is an international, randomized (2:1), double-blind, placebo-controlled Phase 3 study that evaluated the efficacy and safety of Palforzia® in peanut-allergic children aged 1 to 3 years of age in North America and Europe.

The POSEIDON study was completed by Aimmune Therapeutics, part of Nestlé Health Science before Nestlé divested Palforzia® to Stallergenes Greer in September 2023.

Enrollment was based on several entry criteria, including a documented clinical history of peanut allergy, positive skin prick tests and/or elevated blood levels of peanut antibodies, and dose-limiting symptoms after consuming single doses of peanut protein >3 to ≤300 mg in a positive double-blind, placebo-controlled food challenge.

In POSEIDON, patients underwent a dose-escalation period of approximately 22 weeks to reach a dose of 300 mg per day of Palforzia® or placebo, then continued that dose for approximately six months. At the end of the trial, patients underwent an exit double-blind, placebo-controlled food challenge (DBPCFC).

ABOUT STALLERGENES GREER INTERNATIONAL AG

Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of respiratory, food and venom allergies through the development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). For more information, visit www.stallergenesgreer.com.

¹ Summary of Product Characteristics. Rev 06 Sep 2024

² https://evidence.nejm.org/doi/full/10.1056/EVIDoa2300145

Palforzia®: © 2024, Société des Produits Nestlé S.A. or its affiliates

Contacts

Communications

Catherine Kress

Tel: +33 (0)1 55 50 26 05

Email: catherine.kress@stallergenesgreer.com

Neo Medical’s Spine Care Platform Fully Approved Under EU Medical Device Regulation Directive




Neo Medical’s Spine Care Platform Fully Approved Under EU Medical Device Regulation Directive

LAUSANNE, Switzerland–(BUSINESS WIRE)–Neo Medical SA (Neo), a Swiss technology company specializing in spine surgery, today announced the approval of its entire product portfolio under the European Union’s (EU) Medical Device Regulation (MDR) EU 2017/745, confirming compliance with the world’s highest quality control standards for medical devices.

Certification allows Neo to continue supporting customers across all markets, delivering and innovating solutions that seek to improve the long-term outcomes of surgical spine care without interruption.

“Full MDR certification is an important milestone in Neo’s history. From the outset, we committed to a program of long-term clinical evaluation. MDR certification acknowledges the strength and validity of our life-cycle approach to safety, using data to evaluate and guide every step we take,” said Vincent Lefauconnier, Neo’s co-founder and CEO. “The new standards represent a huge step up in stringency for EU medical device certification processes. The tighter oversight has led some manufacturers to reconsider their commercialization strategy in Europe, with 70% of companies manufacturing surgical instruments withdrawing individual products from the EU market.¹ There will be no such impact on our portfolio, and this moment represents a huge opportunity to expand and accelerate our market reach and show our full commitment to our home market.”

Introduced in 2017, MDR aims to create a transparent and sustainable regulatory framework, modernizing the EU regulatory system to better address current market needs and reflect the improved capabilities and potential of new technologies.

The new regulation places even greater emphasis on safety, risk management, and whole-lifecycle oversight for medical devices than the Medical Device Directive (MDD) it replaces. For Class III and Class IIb implantable devices, MDD certification is set to be replaced by MDR at the end of December 2027, and by the end of December 2028 for all other devices.

“MDR approval secures Neo’s ongoing European and global market access, providing a stable foundation for commercial growth and our exciting program of technological development. Ensuring that each and every one of our spine surgery products will be available to all users beyond the 2027 and 2028 deadlines, certification reaffirms our absolute commitment to patient safety and product quality,” added Mr. Lefauconnier.

Compliance with the MDR requires manufacturers to focus on three overall components to market a medical device in the EU.

• Quality management system (QMS): Medical devices must be developed with an appropriate QMS in place, ensuring the device meets its stated purpose through strict controls around design, manufacturing, and post-market, life-cycle oversight.
• Clinical evidence: Clinical evidence requirements are higher for MDR approval than they were in the MDD. Manufacturers must demonstrate the safety and efficacy of their devices with a risk/benefit analysis based on clinical evidence gathered on the devices under approval.
• Regulatory systems and process: Compared to the MDD, the MDR requires more extensive quality control processes and in-depth scrutiny of the technical documentation supporting a full, new conformity assessment process from MDR Notified Bodies, including post-market clinical performance reports, regulated risk management processes, technical documentation, and more.

About Neo Medical

Neo Medical is a Swiss company combining the latest advances in biomechanics and intraoperative augmented reality to set new standards in spine fusion surgery.

Uniquely designed to support treatment of any operable thoracolumbar condition in a single procedural platform, the company’s portfolio seamlessly integrates proprietary force control technologies with first-of-its kind, intraoperative, AI-driven augmented reality data capabilities to improve patient outcomes, reduce environmental impacts, and lower healthcare-associated costs.

Coupling its technologies with a ‘SmartService’ distribution model, Neo Medical’s services optimize processes in and out of the OR, enhancing operational efficiency at every stage of the perioperative process, and contributing to a more sustainable healthcare system.

With a strong European presence and proven leadership, the Company is rapidly expanding in the U.S. and elsewhere around the globe. Based near Lausanne, Switzerland, Neo Medical has operating subsidiaries in the US, Spain, France, and Germany. In addition to the lead investor Gyrus, its shareholding base includes institutional players such as Swisscom Ventures, Verve Ventures, 4FO, and Credit Suisse Entrepreneur Capital.

To learn more, please visit www.neo-medical.com.

References available here.

Contacts

Neo Medical

Max Howells

max.howells@neo-medical.com

Halsin Partners

Mike Sinclair

msinclair@halsin.com

GE HealthCare to Acquire Remaining 50% Stake in Nihon Medi-Physics (NMP), a Leading Radiopharmaceutical Company in Japan, from Sumitomo Chemical




GE HealthCare to Acquire Remaining 50% Stake in Nihon Medi-Physics (NMP), a Leading Radiopharmaceutical Company in Japan, from Sumitomo Chemical

• GE HealthCare to acquire 50% stake from Sumitomo Chemical to assume full ownership of NMP, subject to regulatory approvals
• As part of GE HealthCare, NMP, already a leading radiopharmaceutical company in Japan, will enhance patient access to next-generation radiopharmaceuticals that enable detection and diagnosis of disease
• Acquisition positions NMP to become partner of choice for global innovators looking to bring novel radiopharmaceuticals to Japan and other Asian markets
• Transaction bolsters GE HealthCare’s Pharmaceutical Diagnostics segment and demonstrates its commitment to shaping the future of Molecular Imaging

CHALFONT ST GILES, England–(BUSINESS WIRE)–GE HealthCare (Nasdaq: GEHC) has agreed to acquire full ownership of Nihon Medi-Physics Co., Ltd (NMP), by purchasing from Sumitomo Chemical (TYO: 4005) the 50% stake it does not already own. As part of GE HealthCare, NMP can build on its expertise developing and manufacturing proprietary and in-licensed radiopharmaceuticals used in single photon emission computed tomography (SPECT) and positron emission tomography (PET) molecular imaging procedures to detect and diagnose disease. Sumitomo and GE HealthCare expect the agreement to close in early 2025, subject to regulatory approvals.

NMP’s product portfolio includes GE HealthCare radiopharmaceuticals used to enable clinical images across neurology, cardiology and oncology procedures, such as its amyloid visualization radiotracer, VIZAMYL® Injection (Flutemetamol (¹⁸F) Injection), used in the Alzheimer’s pathway; DaTSCAN® Injection (Ioflupane (¹²³I) injection) used to evaluate patients with suspected Parkinson’s Disease or Dementia with Lewy Bodies; and MYOVIEW® (Technetium (^99mTc) Tetrofosmin), used in SPECT myocardial perfusion imaging for the evaluation of known or suspected coronary artery disease. NMP, headquartered in Tokyo, was formed in 1973 and generated revenues of 28.2B JPY (~$183M) in 2023. In addition to 13 manufacturing facilities, NMP also focuses on research and development, including nonclinical and clinical development of radiotracers and theranostics research. GE HealthCare has held its 50% stake in NMP since acquiring Amersham plc in 2004 and holds three positions on its Board of Directors.

Kevin O’Neill, President & CEO of the Pharmaceutical Diagnostics (PDx) segment of GE HealthCare, said: “As the third largest pharmaceutical market in the world¹, and amongst the leading countries by number of cyclotrons², Japan is on a path to becoming a leader in the $7 billion molecular imaging global market and a center of excellence for Asian markets. NMP will play a key role in that journey, including bringing its deep expertise and scale to global innovators looking to bring novel products to the Japan market and beyond. This will strengthen our precision care strategy in Asia and our existing footprint in Japan, where our contrast media and medical devices are used every day to enable imaging procedures across the country.”

Hiroshi Ueda, Executive Vise President, Sumitomo Chemical, said: “We are proud of our 50-year relationship with NMP and our partnership with GE HealthCare to ensure patients in Japan could benefit from access to molecular imaging. At a time of exciting developments in the industry, following its discussions with Sumitomo Chemical, we believe GE HealthCare is the best owner to enable NMP to continue its successful growth journey. I would like to recognize NMP’s leadership and talented team for their significant achievements to date and their commitment to patients.”

As a leading global medical technology and pharmaceutical diagnostics innovator, GE HealthCare provides both molecular imaging equipment and proprietary radiotracers used across major patient care areas. The recent U.S. FDA approval of GE HealthCare’s first-of-its-kind PET radiopharmaceutical, Flyrcado™ (flurpiridaz F 18 injection), its in-licensing of Phase II FAPI assets and broadening theranostics offerings are all examples of the company’s commitment to novel diagnostics that are shaping the future of molecular imaging to drive improved patient outcomes. GE HealthCare’s PDx segment is a global leader in imaging agents used to support over 120 million patient procedures per year globally, equivalent to four patient procedures every second.

The Company expects this transaction to be neutral to Adjusted EPS^3,4 in year one and accretive thereafter.

GE HealthCare was advised by Solomon Partners Securities, LLC.

Forward-Looking Statements

This release contains forward-looking statements. These forward-looking statements might be identified by words, and variations of words, such as “will,” “expect,” “may,” “would,” “could,” “plan,” “believe,” “anticipate,” “intend,” “estimate,” “potential,” “position,” “forecast,” “target,” “guidance,” “outlook,” and similar expressions. These forward-looking statements may include, but are not limited to, statements about the transaction, the completion and expected results of the transaction, and GE HealthCare Technologies Inc.’s (the “Company’s”) performance, growth opportunities, and strategy. These forward-looking statements involve risks and uncertainties, many of which are beyond the control of the Company. Factors that could cause the Company’s actual results to differ materially from those described in its forward-looking statements include, but are not limited to, the conditions to the completion of the transaction may not be satisfied; closing of the transaction may not occur or may be delayed; the Company may be unable to achieve the anticipated benefits of the transaction; operating costs and business disruptions (including, without limitation, difficulties in maintaining relationships with employees, customers, and suppliers) may be greater than expected; the Company may assume unexpected risks and liabilities; and completing the transaction may distract the Company’s management from other important matters. Other factors that may cause such a difference also include those discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and any updates or amendments it makes in future filings. There may be other factors not presently known to the Company or which it currently considers to be immaterial that could cause the Company’s actual results to differ materially from those projected in any forward-looking statements the Company makes. The Company does not undertake any obligation to update or revise its forward-looking statements except as required by applicable law or regulation.

About GE HealthCare Technologies Inc.

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Advanced Visualization Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits.

Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com for more information.

¹ https://www.trade.gov/country-commercial-guides/japan-pharmaceuticals, accessed on October 29, 2024

² https://nucleus.iaea.org/sites/accelerators/Pages/Cyclotron.aspx, accessed on October 29, 2024

³ See our latest earnings release dated October 30, 2024 for the definition of Adjusted EPS.

⁴ Non-GAAP financial measure

Contacts

GE HealthCare Media Contact:
David Morris

M +44 7920 591370

david.j.morris@gehealthcare.com

Mathilde Bouscaillou

M +33 647 008271

mathilde.bouscaillou@gehealthcare.com

GE HealthCare Unveils Sonic DL for 3D, Expanding Deep Learning Innovations in MRI




GE HealthCare Unveils Sonic DL for 3D, Expanding Deep Learning Innovations in MRI

• New 3D imaging capabilities of Sonic DL are designed to enable up to 86%ⁱ faster scans and enhanced resolution for brain, spine, orthopedic and body imaging.
• Combination of Sonic DL and AIR Recon DL accelerates workflow while improving diagnostic confidence and patient comfort.

CHICAGO–(BUSINESS WIRE)–GE HealthCare (Nasdaq: GEHC) today unveiled Sonic DL for 3Dⁱⁱ, the newest addition to its effortless imaging portfolio, designed to accelerate MRI scans across a wide range of clinical applications. Sonic DL for 3D builds on GE HealthCare’s deep learning innovation legacy and the success of AIR Recon DL, which has helped over 34 million patients to date. Initially launched in 2023 for Cardiac MRI, Sonic DL provides up to 12 times scan acceleration while maintaining diagnostic qualityⁱⁱⁱ. Now, GE HealthCare is extending Sonic DL to 3D volumetric imaging, designing it to broaden its applicability to brain, spine, orthopedic and body exams, in addition to cardiac. This expansion is intended to retain the same impressive 12x acceleration and reduce scan times by up to 86%.

Healthcare burnout has reached critical levels, with 63% of physicians and 49% of nurses reporting symptoms of burnout, according to a 2023 American Medical Association (AMA) survey^iv. Rising workloads, time constraints, and staffing shortages contribute to high stress and fatigue among healthcare professionals, directly impacting patient care. Addressing these challenges, Sonic DL for 3D is designed to help enable faster, high-quality imaging for a majority^v of MR exams. By combining Sonic DL’s speed with AIR Recon DL’s^vi noise reduction technology, this deep learning integration is intended to empower clinicians to significantly cut scan times, enhance image resolution by up to 55%, and enable faster, accurate diagnoses with greater ease.

In neurology, Sonic DL 3D is designed to enable high-resolution imaging of complex brain structures, allowing for quicker, clearer insights into neurological conditions. In orthopedics, it will help to speed up the imaging of joints, ligaments, and bones, reducing scan times to minimize patient discomfort, especially for those with mobility challenges. By advancing speed and clarity in these critical areas, Sonic DL 3D helps to enhance clinical workflows, improve patient comfort, and support timely diagnoses.

“Today’s unveiling of Sonic DL for 3D reinforces our commitment to advancing medical imaging,” said Kelly Londy, President & CEO, Global MR, GE HealthCare. “Our deep learning, effortless imaging portfolio has already seen great success with AIR Recon DL and Sonic DL for cardiac. Now, with Sonic DL’s expansion to 3D and its ability to combine with AIR Recon DL, we’re offering a combination of speed, accuracy, and clarity. We believe Sonic DL will be a game-changer in key clinical areas, substantially impacting our customers’ ability to deliver high-quality care while enhancing the capabilities of their existing systems through seamless upgrades.”

GE HealthCare’s ongoing investment in deep learning technologies, available for both in-field MR upgrades and new installations, supports its vision of sustainable and equitable MR access. By equipping facilities with faster, high-quality imaging solutions, GE HealthCare aims to help healthcare providers reduce patient backlogs, increase exam capacity, and deliver more cost-effective care.

With Sonic DL’s extended capabilities in 3D imaging, GE HealthCare continues to lead as a top provider of AI-integrated MR technology, supporting clinicians in delivering precise, timely diagnostics while enhancing the patient experience^vii.

Learn more about Sonic DL 3D at the Radiological Society of North America (RSNA) Annual Meeting, December 1–4, 2024, in Chicago, or online at gehealthcare.com.

About GE HealthCare Technologies Inc.

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Advanced Visualization Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits.

Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com for more information.

Contacts

GE HealthCare Media Contact:
Kimberly Schmohl

M +1 929 289 1937

kimberly.schmohl@gehealthcare.com

Bayer Showcases Growing Radiology Portfolio at RSNA 2024




Bayer Showcases Growing Radiology Portfolio at RSNA 2024

• Introduction of latest addition to Bayer’s CT product portfolio, MEDRAD® Centargo CT Injection System, which will now be available for radiology departments in the US meeting their growing demand for offerings that simplify, enhance and streamline workflows
• Bayer’s Cortenic™ Connectivity Platform representing a growing connected ecosystem including software and services paired alongside smart injectors
• New clinical data for investigational MRI contrast agent gadoquatrane
• Advancing collaboration with Subtle Medical to harness power of AI 

CHICAGO–(BUSINESS WIRE)–Bayer continues to advance its comprehensive Radiology portfolio with progress in the development pipeline as well as innovations around Artificial Intelligence (AI) and will showcase these advancements at the 2024 Radiological Society of North America (RSNA) Annual Meeting taking place from December 1-5, 2024, in Chicago.

Bayer announced seven collaboration agreements with the aim to further expand the offering of its medical imaging platform Calantic™ Digital Solutions. The company is also presenting new scientific data for gadoquatrane, Bayer’s investigational gadolinium-based contrast agent in Phase III development. In addition, Bayer is also announcing the collaboration with the global med tech company Subtle Medical.

FDA recently clears next generation CT injector

Bayer will also showcase the latest addition to its CT product portfolio, the MEDRAD^(R) Centargo CT Injection System, which recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA). As a multi-patient system, Centargo allows radiology technologists to do less by automating tasks, enabling them more time to focus on patient care, specifically in high-throughput settings. As a smart injector powered by foundational connectivity and cybersecurity, Centargo may also be paired with workflow solutions offerings to help alleviate administrative burdens.

Following regulatory approval in Europe and Canada in 2020, the product has already been launched in 49 markets to date and can now deliver value for radiology departments in the US which is facing a shortage of radiology technologists coupled with a rising demand for medical imaging.

Fostering innovation in Radiology AI

In more than 40 thought leadership presentations, Bayer’s Medical, Regulatory and Product AI team members from Calantic^TM Digital Solutions, Blackford Analysis, and other Bayer Radiology solutions will moderate and showcase insights to help healthcare providers, hospital administrators and developers advance their AI strategy, discussing topics like medical, regulatory, security, and compliance challenges in the field of AI in medical imaging, and how to bring AI-enabled healthcare solutions to market. Developed by radiologists for radiologists, Calantic™ Digital Solutions coordinates various third-party app solutions into a single convenient, cloud-based marketplace. Bayer is also announcing that it will collaborate with new radiology AI technology providers: Rad AI and AIRS Medical for its operational AI service line as well as Contextflow, Gleamer, AZmed, Smart Soft Healthcare, and Lucida Medical for its clinical service lines to further expand its offering on Calantic™ Digital Solutions.

Bayer is also addressing some of the key challenges when it comes to healthcare AI development: In April of this year, the company announced its collaboration with Google Cloud. Bayer’s new AI Innovation Platform (AIIP), a cloud-based end-to-end software development platform designed to help streamline and accelerate the development, validation, and deployment of imaging-based AI/ ML (artificial intelligence/ machine learning) healthcare applications, and built on Google Cloud technology, is now ready for customer testing. AIIP aims to empower the developer teams of healthcare organizations and startups in building scalable and compliant AI-powered medical imaging software products.

Focus on Connected Solutions

Bayer will highlight its focus on creating smarter workflows. Bayer’s Cortenic™ Connectivity platform highlights the importance of data, connectivity, and interoperability across the continuum of care.

New clinical data for investigational contrast agent gadoquatrane – scientific paper awarded with the Kuo York Chynn Neuroradiology Research Award

Gadoquatrane, Bayer’s investigational gadolinium-based contrast agent for MRI, is currently being investigated in Phase III studies There will be two scientific RSNA sessions highlighting new data about the compound.

Gadoquatrane: Pharmacokinetics in healthy volunteers and patients with CNS lesions in combination with MR imaging in comparison to gadobutrol support dose selection for the novel tetrameric GBCA

• Abstract No. M7-SSNR06-1, Session No. M7-SSNR06

The presentation will focus on highlights of a scientific paper which will be honored with the prestigious Kuo York Chynn Neuroradiology Research Award, being given for the top-rated Neuroradiology scientific paper for 2024. The award will be presented to Bayer during the RSNA annual meeting.

Gadoquatrane: Dose-response assessment in MR angiography for the novel tetrameric macrocyclic GBCA in comparison to gadobutrol or gadoterate in a non-clinical and a clinical setting

• Abstract No. S3A-SPNR-16, Session No. S3A-SPNR

Collaboration with Subtle Medical

Bayer is announcing a further extension with the global med tech company Subtle Medical. The companies have agreed to move forward with the development of an investigational AI software in combination with an investigational lower dose of a contrast agent.

About AI in Radiology

The overall global medical imaging AI field, with sales of more than USD 734 million in 2023, is expected to continue growing dynamically. With an estimated compounded annual growth rate of 21 percent, the market is forecast to reach USD 2 billion by 2028. Innovation powered by AI is needed more than ever. Aging populations and changing lifestyles are leading to an increase in chronic conditions, such as cardiovascular disease and cancer. Consequently, the demand for medical imaging to detect diseases, guide treatment decisions and support therapy planning is growing. AI comes with the value proposition of potentially aiding diagnosis and increasing the throughput of radiological examinations.

This is particularly important because time pressure and workload are contributing to the prevalence of burnout among radiologists. This situation is aggravated by the fact that there is a shortage of trained radiologists.

About Calantic Digital Solutions

Calantic Digital Solutions is an orchestrated platform of digital radiology AI-enabled applications that assist radiologists and their teams at critical steps within a patient’s journey. The vendor-neutral, cloud-hosted marketplace includes a growing number of applications designed to aid in prioritization, lesion detection and quantification, as well as apps that automate routine tasks and measurements, help improve radiology suites’ workflow, automate radiology reporting, report impressions, radiology patient follow-up, and interactive patient centered reports designed to free up time for radiologists and their teams, and improve the patient’s journey across the care continuum. The offering is orchestrated by body region and will include tools designed to help with thoracic, neurological, breast, prostate, cardiac and liver imaging, along with operational AI applications.

About Bayer in Radiology

As a true life-science company with a heritage of over 100 years in radiology, Bayer is committed to providing excellence – from innovative products to high-quality services – to support efficient and optimized patient care. Bayer offers a leading portfolio of contrast media for computed tomography (CT), X-ray, and magnetic resonance imaging (MRI), along with devices for their administration, informatics solutions, and a AI medical imaging platform delivering access to individual AI applications. Bayer’s radiology products generated about €2bn sales in 2023.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on LinkedIn: Bayer | Pharmaceuticals
Follow us on Twitter: @BayerPharma

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

PP-CALA-US-0757- 1 November 2024

Contacts

Media Inquiries:
Jennifer May
Email: jennifer.may@bayer.com

GE HealthCare Highlights New Solutions Including AI-enabled Innovations to Drive Precision Care at RSNA 2024




GE HealthCare Highlights New Solutions Including AI-enabled Innovations to Drive Precision Care at RSNA 2024

• Booth (#7330) will showcase new innovations that address the most pressing challenges in healthcare, spanning the care journey across devices, disease states and digital tools
• New product introductions reflect GE HealthCare’s increased R&D investment since 2022

CHICAGO–(BUSINESS WIRE)–At the Radiological Society of North America’s (RSNA) 2024 Annual Meeting taking place from Dec. 1-4 in Chicago, GE HealthCare (Nasdaq: GEHC) will exhibit more than 40 innovations, including several key artificial intelligence (AI)-enabled technologies to optimize patient care and increase operational efficiencies.

GE HealthCare products are designed to increase efficiency and help seamlessly integrate data to support precision care across multiple care pathways. These innovations represent the company’s broader AI and digital strategy, which is focused on integrating AI into medical devices, building AI applications that enhance decision-making across the care journey and disease states, and using AI to support better outcomes.

According to surveys of over 8,000 radiology professionals included in a 2024 report from the American Society of Radiologic Technologists, more than half reported feeling emotionally exhausted, and 57% felt underappreciated on the job.

“Radiologists face challenges that continue to grow, placing extraordinary pressure on an indispensable part of the healthcare imaging and diagnosis journey,” said Peter Arduini, CEO of GE HealthCare. “GE HealthCare is on a mission to deliver technologies that address radiologists’ biggest areas of concern. We are innovating new solutions using the latest AI and digital technologies at the device, care pathway, and enterprise-level, helping clinicians deliver a more personal, precise, and human approach to care from diagnosis to treatment to recovery.”

Simplifying and improving workflows

GE HealthCare offers next-generation solutions and AI-enabled products to streamline workflows and increase efficiency to drive better patient care, clinical decisions or outcomes. The following workflow efficiency technologies will be showcased at the event:

• Clarify DL, 510(k) pending in the U.S., is a bone image reconstruction algorithm powered by AI that is designed to enhance bone SPECT image quality performance, an important factor in increasing diagnostic confidence.*
• nCommand Lite by IONIC Health empowers radiology staff to focus on patient care, while accessing the support needed through remote collaboration and scan assistance. nCommand Lite includes multi-modality capabilities in support of magnetic resonance (MR), computed tomography (CT) and positron emission tomography/CT (PET/CT) scanning.
• True PACS and v7 PACS solution, now supports Blackford’s AI orchestration platform and selective 3^rd party AI based imaging applications, providing seamless integration of AI in the reading workflow to help radiologists and clinicians provide quick and accurate diagnosis for patients.¹ The collaboration enables True PACS and v7 PACS solution customers to directly acquire Blackford Analysis’ AI-enabled platform with a catalogue of third-party AI applications that span across various clinical area use cases, ranging from mammography to lung scans.²
• MR Max 3™, a wireless syringeless power injector for gadolinium-based contrast media is compatible with multiple contrast bottle sizes, including 24-hour multiuse containers (Imaging Bulk Packaging). The syringeless injector enhances workflow efficiency, lowers plastic waste consumption, and enables contrast optimization through the use the efficient use of Imaging Bulk Packaging containers, thus further reducing overall departmental cost by reducing contrast waste.
• Caption Guidance™ is AI-driven technology powered by deep learning image analysis algorithms that guide users on how to adjust the ultrasound probe. The software provides real-time, step-by-step instructions to ensure that the cardiac ultrasound images captured meet the diagnostic standard.
• Venue Sprint™, a portable system in a tablet form, and the latest Venue family solution offering maximum portability and advanced capabilities for high-quality scanning and support at the point of care. Venue family ultrasound systems will also integrate wireless Vscan Air dual-probes and have access to Caption Guidance.
• Vscan Air SL handheld ultrasound system now features Caption AI, including Caption Interpretation AutoEF software, which automatically calculates a left ventricular ejection fraction (LVEF)—an important measure of heart function. In addition, Digital Tools for Vscan Air offers key tools to securely store and share images in the cloud. At RSNA, GE HealthCare will launch a new trial of Digital Tools for both existing and new Vscan Air users to evaluate new software.

Precise and personalized care

GE HealthCare strives to support health systems by delivering a personalized care pathway for each patient. GE HealthCare’s integrated cancer care products leverage digital, AI and our suite of innovative solutions along with imaging technologies and radiopharmaceuticals. These components are designed to enhance diagnoses, drive productivity, increase value, speed and efficiency, and improve overall patient health.

At the event, GE HealthCare has several new oncology technologies that help provide personalized care:

• Aurora, 510(k) pending in the U.S, is a new dual head SPECT/CT, designed to help clinicians solve operational and diagnostic challenges as well as develop personalized approaches for better patient outcomes. It integrates deep learning image reconstruction and a collection of advanced CT clinical and effortless workflow solutions designed to help support better patient care.*
• GE HealthCare and RadNet recently announced a strategic collaboration that will leverage GE HealthCare’s legacy and scale of imaging innovation and RadNet’s DeepHealth AI-powered clinical and workflow solutions to further the innovation, commercialization, and adoption of AI in imaging. Together, GE HealthCare and DeepHealth aim to create SmartTechnology™ solutions that harness the power of AI to help redefine radiology workflows and address key challenges across the imaging value chain to improve speed, clinical accuracy, operational efficiency, and elevate patient care.
• Senographe Pristina Via is an advanced mammography system that introduces innovative features designed to support technologist workflow and streamline the image acquisition process.
• CareIntellect for Oncology is a new cloud-first application that brings together multi-modal patient data from disparate systems into a single view, using generative AI to summarize clinical notes and reports. This solution also surfaces relevant data allowing care teams to quickly understand disease progression and flag potential deviations from the treatment plan to help the clinician determine next steps and inform proactive interventions. The application is planned to be available in the U.S. in 2025, initially focusing on prostate and breast cancer. The company aims to quickly expand into new disease types and care areas. Tampa General Hospital and UT Southwestern Medical Center will be early evaluators of CareIntellect for Oncology, and integration is already underway.

In addition, theranostics is a rapidly growing field of molecular imaging leveraging radiotracers and diagnostic imaging equipment including PET and SPECT systems to precisely diagnose and monitor disease for the targeted delivery of therapy to patients. These therapeutic and diagnostic technologies work together to provide a personalized, highly precise, patient-centric approach to medical diagnosis and treatment.

“Cancer care requires a personalized approach across the care continuum – from early detection and diagnosis, to planning, intervention and monitoring – to help improve patient outcomes,” said Roland Rott, president and CEO of Imaging at GE HealthCare. “Because of our comprehensive solutions and expertise in the healthcare industry, GE HealthCare is uniquely positioned to support every step of the theranostics care pathway while helping solve diagnosis challenges and develop personalized approaches.”

GE HealthCare has recently announced new theranostics-related innovations including:

• MINItrace Magni (MI) is helping expand access to tracer production programs and making theranostics more accessible by delivering a compact, cost-effective cyclotron capable of reliable, in-house PET tracer and radiometal production with solid target technology.³
• Omni Legend now with 21 cm configuration is designed to evolve with healthcare system needs across care areas, including shorter scan times and lower doses without compromising image quality in oncology, support for increasing PET amyloid imaging in Alzheimer’s diagnosis and treatment follow up in neurology, and cardiac diagnostics. It accommodates a range of tracers including fast decay and emerging tracers in cardiology. These capabilities are further enhanced with Precision DL, an innovative deep learning-based image processing software that is engineered to provide increased small, low-contrast lesion detectability compared to our conventional Time-of-Flight PET/CT scannerⁱ.
• Flyrcado™ (F18 Flurpiridaz) injection is a first of its kind approved by U.S. FDA positron emission tomography myocardial perfusion imaging (PET MPI) agent, for the enhanced detection of coronary artery disease (CAD). Flyrcado delivers higher diagnostic efficacy in patients with known or suspected CAD, compared to SPECT MPI, the predominant procedure used in nuclear cardiology today.
• GE HealthCare’s MIM Software received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to perform absorbed dose calculation of radionuclides using a Monte Carlo method. With this clearance, Monte Carlo dosimetry via the Dose Planning Method (DPM) will be available for use with MIM SurePlan MRT, MIM Software’s comprehensive solution. This vendor agnostic technology turns the otherwise cumbersome process of performing dosimetry into a clinically realistic process via automation and standardization. In just a few clicks, and with built-in guidance, users can review absorbed doses.

Additional new products that will be demonstrated in the booth:

• Versana Premier is a multi-purpose, budget-friendly ultrasound system equipped with automation and AI-enabled productivity tools to improve workflow and clinical features designed to enhance clinical efficiency and accuracy. The system includes Digital Expert Connect, allowing users to easily collaborate virtually with colleagues across their network.
• True Enhance DL on Revolution Ascend platform is a dedicated Deep Neural Network (DNN) designed to increase contrast to support confident diagnoses in CT exams. The AI-based solution provides clinicians a simple workflow and incredible CT image quality.
• TrueFidelity DL on Revolution Apex and Revolution Ascend platforms is an image reconstruction technology that uses a Deep Neural Network to generate high-def, low-noise CT images with exceptional sharpness and low-contrast detectability with customer-preferred noise texture, at the same dose.⁴ This includes cardiac images, helping reduce noise and increase image sharpness.
• SIGNA™ MAGNUS is an FDA 510(k) cleared head-only magnetic resonance (MR) scanner designed to explore advancements in neuroscience, which have been restricted by the performance limitations of conventional whole-body MR systems.⁵

For more information on GE HealthCare and these innovative solutions at RSNA, visit Booth 7330, our press kit, or the RSNA 2024 events page.

INDICATIONS AND USAGE OF FLYRCADO™:

Indications and Usage

FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction.

Contraindications

None

Warnings and Precautions

• Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent’s prescribing information.
• Radiation risks: FLYRCADO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void.

Adverse Reactions

• Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia.

For full prescribing information, click here. For important safety information, please click here.

About GE HealthCare Technologies Inc.

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Advanced Visualization Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits.

Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com/ for more information.

¹ True PACS is a solution which contains Universal Viewer, Enterprise Archive, Centricity Universal Viewer ZeroFootprint Client, Blackford AI Orchestrator and 3rd party clinical AI apps.

² All clinical applications are not available in all countries.

³ MINItrace disclaimer: Technology in development that represents ongoing research and development efforts. These technologies are not products and may never become products. Not CE marked.

⁴ Image quality comparisons were evaluated by phantom tests of MTF, SSP, axial NPS, standard deviation of image noise, CT Number accuracy, CNR, and artifact analysis. Additionally, LCD was demonstrated in phantom testing using a model observer with the head and body MITA CT IQ Phantoms (CT191, CT189 The Phantom Laboratory). DLIR-H and ASiR-V reconstructions were performed using the same raw data.

⁵ 510(k) cleared. Not CE marked. Not available for sale in any region.

* 510(k) Pending at the U.S. FDA. Not Available for Sale in the United States. Not all products and solutions are available in all countries. Please contact your GE HealthCare representative to confirm availability.

ⁱ At matched scan time and injected dose. Detectability using clinical data with an inserted 8 mm diameter liver lesion of known location and 2:1 contrast using a CHO model observer, comparing SNR from Omni Legend 32 cm with QCHD and Precision DL to SNR from Discovery™ MI 25 cm with QCFX.

Contacts

Linh Dinh

Global Communications Director

M 408.275.5682

linh.dinh@gehealthcare.com