Category Archives: Biotech Companies Medical Devices Medtech

Protembis Announces Completion of € 30 Million Series B Financing Round and the Addition of Keith D Dawkins MD to the Board of Directors

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AACHEN, Germany–(BUSINESS WIRE)–#CerebralProtection–Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the completion of a € 30 million Series B financing round to support the enrollment of the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816). The funding round was structured in two separate capital increases which have both been completed. It was co-led by a European consortium of VC investors including Sweden-based Segulah Medical Acceleration, Italy-based XGEN Venture, and Germany-based TechVision Fund. Other investors include Coparion, several large family offices, angel investors and a multinational medical device strategic.

“We are delighted to announce the completion of the round and would like to thank our existing investors as well as the new investors for their trust and confidence,” said Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis. “It reflects the fact that the field of cerebral embolic protection is buoyant, and that future growth will be driven by younger and lower risk patients who have zero tolerance for brain injury risk when selecting to undergo transcatheter aortic valve replacement.”

Additionally, Protembis is proud to announce the addition of Keith D. Dawkins, MD, to the Board of Directors. Dr Dawkins has more than 35 years’ experience in the cardiovascular environment. With over 20 years as a practicing interventional cardiologist in the UK he has held research roles as a Fulbright Scholar at Stanford University, served as President of the British Cardiovascular Intervention Society, and authored more than 750 academic publications and presentations. Dr Dawkins has been the Chief Medical Officer (CMO) of Shockwave (NASDAQ:SWAV) since 2019, and this was preceded by his role as Global CMO at Boston Scientific where he held senior positions since 2008. He also serves as a member of the boards of Ventric Health LLC and JenaValve Technology Inc., as well as Chairman of InnovHeart s.r.l. Dr Dawkins will contribute his significant expertise to the clinical strategies of Protembis and the pre-commercial programs as the IDE study reaches its conclusion.

“To have such a visionary leader as Dr Dawkins join our Board of Directors is an exciting indication of the opportunities that cerebral embolic protection holds for future transcatheter therapies. We look forward to close collaboration as the field develops and our superiority trial gains momentum,” said Azin Parhizgar, PhD, Chairwoman of the Board of Directors.

“As a long-term believer in the need to protect the brain from all new lesions during transcatheter aortic valve replacement, I am very pleased to join Protembis,” said Dr Dawkins. “The ProtEmbo System and the clinical trial design are both novel and I am confident that they will be highly disruptive to the field of cerebral embolic protection, removing or mitigating many of the current issues that concern the physician community.”

About ProtEmbo® and Protembis

The ProtEmbo® Cerebral Protection System is an intra-aortic filter device that protects the entire brain from embolic material liberated during transcatheter aortic valve replacement (TAVR). It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment typically delivered through the femoral artery.

Protembis is a privately held emerging medical device company that has developed the ProtEmbo® Cerebral Protection System. The company strives to provide a simple and reliable solution to protect patients from brain injury during left-sided heart procedures, improving patient quality of life and reducing overall healthcare costs associated with brain injury during such procedures. The ProtEmbo System is currently undergoing clinical investigations.

Contacts

Protembis GmbH

Conrad Rasmus & Karl von Mangoldt

+49(0)241 9903 3622

management@protembis.com
www.protembis.com

Mainstay Medical Announces US$125 Million Equity Financing Transaction

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Funding to accelerate commercial growth and expand clinical and health economic evidence for ReActiv8® Restorative Neuromodulation™ System

DUBLIN–(BUSINESS WIRE)–Mainstay Medical Holdings plc today announced an equity financing in which it will receive gross proceeds of US$125 million. Mainstay intends to use the funds to support the company’s continued commercial growth of ReActiv8® Restorative Neurostimulation in the U.S., Europe and Australia, additional post-market clinical studies and research, and general operations.


The financing was co-led by new investors Gilde Healthcare and Viking Global Investors. Key existing investors who participated in the financing include Ally Bridge Group, Sofinnova Partners (Crossover Fund), Fountain Healthcare Partners, and Perceptive Advisors.

“A financing of this magnitude will allow us to accelerate our efforts to revolutionize the treatment of mechanical low back pain through ReActiv8 Restorative Neurostimulation, including by continuing our rapid commercial growth and building on our insurance coverage for ReActiv8,” said Jason Hannon, CEO of Mainstay Medical. “We are now strongly capitalized to execute on our corporate objectives. In addition to commercial expansion in our target markets, these objectives include the generation of additional clinical and health economic data to further demonstrate that ReActiv8’s purpose-built, restorative approach to the treatment of mechanical chronic low back pain is superior to competitive therapies originally designed for other indications, as well as the continued development and enforcement of our dominant intellectual property portfolio.”

“We are excited to lead this financing and to work with Mainstay to continue to unlock the potential of ReActiv8 therapy,” said Geoff Pardo, Partner at Gilde Healthcare, who also joins the Mainstay Medical Board of Directors. “Patients with mechanical chronic low back pain have had very limited treatment options, and the restorative mechanism of action offered by ReActiv8 is both unique and very promising.”

Two extraordinary general meetings of Mainstay shareholders were held on 23 February 2024 to approve the financing and related matters. At the EGMs, all resolutions were duly passed. The results of the voting on each of the resolutions is available on the Company’s website.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

Further information can be found at www.mainstaymedical.com.

Mainstay Forward-Looking Statements

All statements in this announcement other than statements of historical fact are, or may be deemed to be, forward-looking statements. These forward-looking statements may include, without limitation, statements regarding the company’s intentions, beliefs or current expectations concerning, among other things, the company’s funding needs, strategies, alternatives and transactions, ability to fund its objectives moving forward, commercial efforts and performance, research studies and results, financial position, product design and development, intellectual property portfolio and its scope, regulatory applications and approvals, and reimbursement arrangements.

Forward-looking statements involve risk and uncertainty and are not guarantees of future performance. Actual results may differ materially from those described in, or suggested by, the forward-looking statements. A number of factors could cause results and developments to differ materially from those expressed or implied by the forward-looking statements herein, including, without limitation, the risks and uncertainties included in the company’s Annual Report for the year ended 31 December 2022, which should be read in conjunction with the company’s public disclosures (available on the company’s website (www.mainstaymedical.com)). The forward-looking statements herein speak only as of the date of this announcement.

Contacts

Mainstay PR and IR Enquiries:

LifeSci Advisors, LLC
Brian Ritchie

Tel: + 1 (212) 915-2578

Email: britchie@lifesciadvisors.com

FTI Consulting (for Ireland)

Jonathan Neilan or Patrick Berkery

Tel. : +353 86 602 5988

Email: mainstay@fticonsulting.com

Mainstay Medical
Corporate Communications

Email: Media@mainstaymedical.com

A new clinical study highlights efficiency in spine surgery of NextAR Spine, augmented reality surgical application

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A new clinical study highlights efficiency in spine surgery of NextAR Spine, augmented reality surgical application

CASTEL SAN PIETRO, 14 December 2023 – Medacta Group SA (“Medacta”, SIX:MOVE), a Swiss company specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgeries, announces the publication of a new study in the European Spine Journal which demonstrates that NextAR Spine seamlessly integrates into the OR workflow, enabling the surgeon to enhance efficiency, accuracy, and versatility in spine surgery.

“Precision and accuracy in spine surgery is critical. As stated in our recent study, NextAR, the new AR-assisted navigation system, greatly simplifies pedicle screw placement, ensuring effectiveness and accuracy. It’s a reliable tool, straightforward to use, and it elevates our ability to provide safe and precise navigation for various spinal conditions,” says Professor Dr. med. Bernhard Meyer, Director of the Neurosurgical Clinic and Policlinic at the University Hospital Rechts der Isar, Munich.

The study “Evaluating a cutting‑edge augmented reality‑supported navigation system for spinal instrumentation”1 led by Prof. Dr. med. Bernhard Meyer, evaluates the efficiency, accuracy, and versatility of NextAR Spine, a navigation system that incorporates augmented reality to provide unique real-time surgical guidance, superimposed onto the operative field, enhancing precision and enabling data-driven decision-making in the placement of pedicle screws, and addressing different types of spine indications, such as trauma, degeneration, infection, and tumor.

The placement of pedicle screws has been achieved with precision using both open and percutaneous approaches in both long and short constructs, indicating a lower intraoperative revision rate (1.7%)1 compared to the rate documented in the scientific literature with other navigation systems (3.4% by Ille at al2; 4.7% by Ryang at al3). This further highlights that NextAR Spine proves to be a reliable and safe tool for 3D imaging-based pedicle screw placement while requiring minimal setup during surgery, in line with Medacta’s philosophy of healthcare sustainability. The setup is reduced to a minimum by integrating the cameras into the surgical instruments and establishing a flexible platform which includes the preoperative planning.

The NextAR platform is offered as a hardware system with limited capital investment and single-use instrumentation at a low cost per case and offers the ability to host software for multiple applications (NextAR Knee, NextAR Shoulder, NextAR Spine, and Hip applications). The platform represents an optimal solution worldwide, particularly for US Ambulatory Surgery Centers (ASCs).

The NextAR surgical platform is part of Medacta’s MySolutions Personalized Ecosystem, a network of advanced digital solutions designed to improve patient outcomes and healthcare efficiency. MySolutions embodies Medacta’s holistic approach to personalized medicine, aiming at bringing value to every step of the patient’s journey, from preoperative through postoperative care.

NextAR is also supported by the comprehensive, tailored educational offerings provided by the M.O.R.E. Institute. With an international network of expert surgeons, the M.O.R.E. Institute is at the forefront of education on spine procedures and products with personalized high-level educational pathways. With Medacta, the surgeon is never alone.

REFERENCES
[1] Schwendner M, Ille S, Wostrack M, Meyer B. Evaluating a cutting-edge augmented reality-supported navigation system for spinal instrumentation. Eur Spine J. 2023 Nov 14. doi: 10.1007/s00586-023-08011-w. Epub ahead of print. PMID: 37962688.
[2] Ille S, Baumgart L, Obermueller T, Meyer B, Krieg SM (2021) Clinical efficiency of operating room-based sliding gantry CT as compared to mobile cone-beam CT-based navigated pedicle screw placement in 853 patients and 6733 screws. Eur Spine J 30(12):3720–3730. https:// doi. org/ 10. 1007/ s00586- 021- 06981-3
[3] Ryang YM, Villard J, Obermuller T et al (2015) Learning curve of 3D fluoroscopy image-guided pedicle screw placement in the thoracolumbar spine. Spine J 15(3):467–476. https:// doi. org/ 10. 1016/j. spinee. 2014. 10. 003    
 

Contact

Medacta International SA
Gianluca Olgiati     
Senior Director Global Marketing  
Phone: +41 91 696 60 60
media@medacta.ch

 

About Medacta

Medacta is an international company specializing in the design, production, and distribution of innovative orthopaedic products, as well as in the development of accompanying surgical techniques. Established in 1999 in Switzerland, Medacta is active in joint replacement, spine surgery, and sports medicine. Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Medacta’s innovation, forged by close collaboration with surgeon experts globally, began with minimally invasive surgical techniques and has evolved into personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 50 countries. Follow us on Medacta TV, YouTube, LinkedIn, and X.

 

 

 

Additional features:

File: MEDIA RELEASE – A new clinical study highlights efficiency in spine surgery of NextAR Spine, augmented reality surgical application

End of Media Release

Language: English
Company: Medacta Group SA
Strada Regina
6874 Castel San Pietro
Switzerland
Phone: +41 91 696 6060
E-mail: info@medacta.ch
Internet: www.medacta.com
ISIN: CH0468525222
Listed: SIX Swiss Exchange
EQS News ID: 1796547

 
End of News EQS News Service

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Nanostics – micro-flow cytometry to quantify extracellular vesicle size, concentration and marker abundance, with advanced machine learning algorithms to determine disease states

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Nanostics is focused on development and commercialization of novel, non-invasive diagnostic tests for cancer. Its core technology is an advanced liquid biopsy platform that can accurately diagnose cancer from a single drop of blood. Its lead product, ClarityDx Prostate, is the most accurate diagnostic test to diagnose aggressive prostate cancer, and is positioned to emerge as the world’s leading diagnostic tool for prostate cancer.

Nanostics - micro-flow cytometry to quantify extracellular vesicle size, concentration and marker abundance, with advanced machine learning algorithms to determine disease states

EVs carrying disease-specific biomarkers like nucleic acid and proteins are continuously released from cells and can be found in biological fluids including blood, urine, semen, and cerebrospinal fluid.  The levels of disease-specific EVs are closely related to disease progression making EVs promising targets for minimally invasive diagnostic assays.

Technology designed to accurately detect and measure EVs has the potential to greatly improve liquid biopsy diagnostics. At Nanostics, we use micro-flow cytometry (µFCM) to quantify EV size, concentration, and marker abundance for millions of EVs in minutes. We then use advanced machine learning to analyze the vast amount of data generated using µFCM to provide rapid and precise results that continuously improve with every test.

The EV and machine learning platform ClarityDX® is set to transform the diagnostic landscape and make easy-to-use, minimally invasive predictive tests a reality in the near future.

At Nanostics, we use micro-flow cytometry (µFCM) to quantify EV size, concentration, and marker abundance for millions of EVs in minutes. We then use advanced machine learning to analyze the vast amount of data generated using µFCM to provide rapid and precise results that continuously improve with every test.

The EV and machine learning platform ClarityDX® is set to transform the diagnostic landscape and make easy-to-use, minimally invasive predictive tests a reality in the near future.

The ability to detect and measure EVs is transforming the diagnostic landscape in immunology, neurology, cardiology, and oncology. The ClarityDX® platform technology is well-positioned for future pipeline products including tests for screening, early diagnosis, complementary diagnosis, monitoring, and management for many diseases and medically-related events. Nanostics’ R&D team continues to expand the product pipeline through in-house and partnered projects to include additional liquid biopsy diagnostic tests to improve patient care.

Nanostics – micro-flow cytometry to quantify extracellular vesicle size, concentration and marker abundance, with advanced machine learning algorithms to determine disease states

More info : http://www.nanosticsdx.com

Keywords : machine learning, exosomes, extracellular vesicles, diagnostics, oncology, cancer, prostate cancer, cardiovascular, neuroscience, biofluids , liquid biopsy , micro-flow cytometry

Glycorex Transplantation – removing antibodies from blood to improve transplantation and fight autoimmune diseases

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Glycorex’s unique molecular level technology that specifically selects and removes antibodies in the blood has opened up ground-breaking treatments and solutions in healthcare. The company’s medical devices enable transplants across the blood groups saving lives and providing health economic benefits by increasing the number of transplants. The company’s technology to treat blood is applied in several health care settings and a new disruptive product has recently been launched with the potential to increase availability of blood plasma. Several new products for the treatment of autoimmune diseases are under development.

Glycorex Transplantation - removing antibodies from blood to improve transplantation and fight autoimmune diseases

In addition to kidney transplants, our product, Glycosorb® ABO, is used in several other types of transplants, such as liver, heart and stem cell transplants. More than 60 scientific papers with Glycosorb® ABO show excellent short- and long-term results fully comparable to blood group compatible transplants. Thanks to Glycosorb® ABO, blood group incompatible transplants are now routinely performed in many countries.

With our unique technology as a base, we are currently expanding into new interesting applications. In the area of transfusion medicine, we have recently launched a product intended to be used for donated plasma to produce universal blood plasma which can be given regardless of the recipient’s blood group, which means major improvements in logistics, safety and availability.
The focus of our development work is now to develop new treatments for severe autoimmune diseases. The closest to launch is a specific treatment for rheumatoid arthritis (RA) – a disease that has affected around five million people in Europe.

Glycorex Transplantation AB (publ) is based in Lund, Sweden, and its shares are listed on NGM – Main Regulated, Stockholm (NGM: GTAB B).

Glycorex Transplantation – removing antibodies from blood to improve transplantation and fight autoimmune diseases

More info : Glycorex Transplantation AB

Keywords : transplantation, autoimmune diseases, Rheumatoid Arthritis, antibodies hematology

MJN Neuroserveis – predicting epileptic seizures

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MJN Neuroserveis - predicting epileptic seizures

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