Month: April 2024

JACKSONVILLE, Fla. – April 8, 2024 – MMI (Medical Microinstruments, Inc.), a robotics company dedicated to increasing treatment options and improving clinical outcomes for patients with complex conditions, today announced that its Symani Surgical System is now commercially available in the United States. The U.S. Food and Drug Administration (FDA) granted De Novo Classification to the robotic system for soft tissue manipulation to perform microsurgery, a highly specialized technique that involves reconnecting tiny vessels to restore blood flow or redirect fluid during reconstruction or repair.

The FDA authorization makes the Symani Surgical System the only commercially available platform in the U.S. for reconstructive microsurgery. The technology is positioned to open the field of microsurgery to new surgeons by quickly developing their skills, as well as to empower skilled microsurgeons to confidently expand into supermicrosurgery, creating a novel category of treatments that the human hand cannot perform without robotic assistance.

“The U.S. is facing a potentially dire shortage of physicians, and that shortage acutely impacts specialized fields of medicine, such as microsurgery,” said Mark Toland, CEO of MMI. “With the authorization from the FDA, our technology will expand its reach to pioneering hospitals in the U.S. It will help those hospitals grow their open surgical programs, expand the number of physicians who can perform these highly complicated procedures, and increase patient access to the most advanced techniques for surgeries in complex disease states, such as lymphedema. Our system will continue to provoke surgeons to challenge their definitions of ‘treatable’ and ‘untreatable’ and empower them to solve cases that have historically been too difficult to treat.”

Specific techniques used in microsurgery include reconnecting small anatomical structures, such as blood and lymphatic vessels, during open surgical procedures. Supermicrosurgery involves reconstruction or repair of even smaller vessels, typically less than 1mm in diameter, and fewer than 600 surgeons worldwide perform supermicrosurgery today.

The Symani Surgical System provides advanced solutions for a range of open surgeries, including post-mastectomy breast cancer reconstruction, extremity reconstruction using free tissue transfer, and lymphatic system repair.

“By making open surgery less invasive and more precise, we can treat more conditions and offer robotic-assisted surgical options to patients that simply do not exist today,” said Dr. L. Scott Levin, co-CMO of MMI. “Within the next five years, this expanded portfolio of addressable open surgical procedures is expected to exceed the number of eligible laparoscopic, or minimally invasive, procedures that leverage robotic assistance. The authorization from the FDA helps to solve a critical unmet need and will help surgeons perform a new category of complex open surgeries enabled by transformative technology.”

The Symani Surgical System offers surgeons entirely new capabilities because it features the world’s smallest surgical robotic wrist, called NanoWrist®. The unique design enables surgeons to replicate the natural movements of the human hand at the micro scale, which encourages a flatter learning curve in the training process. The articulated wrist features seven degrees of freedom that match the human wrist, tremor filtration and motion scaling, ultimately increasing precision and control.

Surgeons have leveraged the Symani Surgical System in nearly 1,000 clinical cases in the European Union and in thousands of preclinical cases around the world. The Symani Surgical System is available for commercial use in Europe and parts of Asia Pacific. MMI plans to immediately launch the technology in the U.S.

To learn more about MMI and the Symani Surgical System, visit MMI’s website here: https://mmimicro.com.

EINDHOVEN, the Netherlands — April 2, 2024 — ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to improve or restore movement, function, and independence in people with spinal cord injury (SCI), today announces it has submitted its De Novo application to the US Food and Drug Administration (FDA) to allow marketing of its breakthrough ARC-EX System to restore function of the upper extremities after SCI.

The submission marks an historic milestone for the Company in its mission to restore mobility and function for people with SCI. Once cleared by the FDA, ARC-EX will be the first-ever spinal cord stimulation therapy to restore hand and arm function after SCI and the first commercial product for ONWARD Medical. ONWARD prioritized upper limb function as its first indication for the ARC-EX System given feedback from the SCI Community of the importance of arm, hand, and finger function in empowering independence after SCI.

“We are delighted to be one step closer to bringing our breakthrough ARC-EX System to people living with SCI after submitting this De Novo application for regulatory clearance in the United States,” said ONWARD Medical CEO Dave Marver. “This therapy has the potential to transform the lives of people living with paralysis, while also positively impacting their loved ones.”

The De Novo application follows the Company’s global pivotal study – called Up-LIFT – the first large-scale pivotal study of transcutaneous spinal cord stimulation. The study investigated the safety and effectiveness of ARC-EX Therapy in improving upper limb strength and function in 65 study participants with chronic tetraplegia at 14 leading SCI neurorehabilitation centers in the United States, Canada, the United Kingdom, and the Netherlands. The study met all primary safety and effectiveness endpoints and demonstrated that 72% of participants responded to ARC-EX Therapy1, showing improvement both in strength and function.

“The SCI Community is eager to have access to this innovative technology,” said Candy Tefertiller, PT, DPT, PhD, NCS, Executive Director of Research and Evaluation, Craig Hospital in Lakewood, Colorado. “Even a small difference in hand and arm function can have a profound impact on independence and quality of life. The results of the Up-LIFT trial that led to this submission represent a significant advancement in the use of neuromodulation for individuals with spinal cord injury.”

The ONWARD ARC-EX System delivers ARC-EX Therapy™ – targeted, programmed electrical stimulation – transcutaneously to the spinal cord to increase strength, movement, and function of the upper limbs after SCI. The ARC-EX System was previously awarded FDA Breakthrough Device Designation (BDD) for upper limb function, which provided prioritized FDA review, the opportunity to interact with FDA experts, and the potential for additional reimbursement.

Nearly 200,000 people in the US and Europe have incomplete impaired upper extremity function after spinal cord injury.2,3 The Company is preparing for regulatory submission in Europe next.

To learn more about ONWARD Medical’s commitment to partnering with the SCI Community to develop innovative solutions for restoring movement, function, and independence after spinal cord injury, please visit ONWD.com.

*All ONWARD Medical devices and therapies, including but not limited to ARC-IM®, ARC-EX®, ARCBCI™, and ARC Therapy™, alone or in combination with a brain-computer interface (BCI), are investigational and not available for commercial use.

PHILADELPHIA, April 1, 2024 /PRNewswire/ — Carisma Therapeutics Inc. (Nasdaq: CARM) (“Carisma” or the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced the appointment of John Hohneker, M.D. to the Board of Directors of the Company, effective April 1, 2024. Additionally, the Company announced that Chidozie Ugwumba, who has served on Carisma’s Board of Directors since December 2020, has advised the Board of his intent to step down from his role as a member of the Board and chair of the Audit Committee of the Board effective April 1, 2024, as a result of his other professional commitments.

“We are pleased to welcome John to the Carisma Board of Directors,” said Sanford Zweifach, Chair of the Carisma Board of Directors. “I believe John’s extensive track record of clinical development, strategic leadership, and public company Board membership in the biopharmaceutical space will enable him to immediately support the Company as it continues leading the field of engineered macrophage development. We would also like to thank Chidozie for his invaluable advice and guidance since he first joined the Board over three years ago.”

“I am excited to join Carisma’s Board as the Company continues to develop innovative immunotherapies,” said Dr. Hohneker. “I am looking forward to partnering with the Board and the management team as they work to potentially bring novel treatments to patients in need across multiple therapeutic areas.”

Dr. Hohneker brings over 30 years of extensive experience in drug development and leadership across the biotech and pharmaceutical sectors. He most recently served as President and Chief Executive Officer of Anokion SA. Prior to this, he held the role of President of Research and Development at FORMA Therapeutics Inc. Before joining FORMA Therapeutics, Dr. Hohneker held roles of increasing responsibility at Novartis AG, including most recently as Senior Vice President and Global Head of Development, Immunology, and Dermatology. Prior to his time at Novartis, Dr. Hohneker held positions of increasing responsibility at Glaxo Wellcome and its legacy company, Burroughs Wellcome.

Dr. Hohneker currently serves on the Board of Directors of Curis, Inc., Sonata Therapeutics, Inc., and Trishula Therapeutics, Inc. Previously, Dr. Hohneker has served as a member of the Board of Directors of Torque Therapeutics, Inc., Dimension Therapeutics, Inc., Cygnal Therapeutics, Inc., BioTheryX Inc., Evelo Biosciences, Inc., Humanigen, Inc. and Aravive, Inc. Dr. Hohneker received his bachelor’s degree in chemistry from Gettysburg College and his M.D. from the Rutgers School of Biomedical and Health Sciences (formerly the University of Medicine and Dentistry of New Jersey-Rutgers Medical School). He completed his internship and residency in internal medicine and his fellowship in medical oncology, all at the University of North Carolina at Chapel Hill.