Business Roundup: Advancing new therapies for Parkinson’s disease and more
Neuro Rehab Times explores the latest business and pharmaceutical developments in the world of neuro-rehabilitation.
US$32m to advance left atrial appendage occlusion technology
Medical device company Conformal Medical, has raised US$32m to advance its left atrial appendage occlusion technology.
The funds will support the enrolment of the company’s ongoing CONFORM Pivotal Trial and fund key pre-commercialisation initiatives for the CLAAS AcuFORM LAAO system which is is designed to seal the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation (AFib) to reduce the risk of stroke without the need for anticoagulants.
The CONFORM Pivotal Trial is the company’s clinical trial evaluating the safety and efficacy of the CLAAS System compared to other commercially available LAAO devices and will support U.S. Food and Drug Administration (FDA) pre-market approval.
“We are pleased to have treated over 100 patients with the next-generation AcuFORM™ System, with impressive deliverability and safety performance to date,” said James Reinstein, president and CEO of Conformal Medical.
“We look forward to building upon this robust body of evidence to further validate our one-size strategy, and the promising experience from our GLACE trial, demonstrating successful use of ICE guidance as it would eliminate the need for general anesthesia and intubation for these procedures.”
Conformal Medical’s proprietary CLAAS AcuFORM technology features a foam-based architecture designed to conform to a broad range of LAA anatomies with only two sizes.
The AcuFORM device may also accelerate the shift to ICE-guided LAAO closure due to simplified sizing and seal confirmation, thereby potentially eliminating the need for a procedural transesophageal echocardiogram and general anesthesia.
The company remains focused on completing the CONFORM and GLACE clinical trials to demonstrate its safety profile and ability to offer breakthrough solutions that address unmet clinical needs and transform the way Left Atrial Appendage Occlusion is treated.
LITE programme to advance new therapies targeting LRRK2 for Parkinson’s Disease
Seal Rock Therapeutics has joined The Michael J. Fox Foundation for Parkinson’s Research (MJFF) LRRK2 Investigative Therapeutics Exchange (LITE) programme.
The LITE program supports the development of new therapies targeting LRRK2 for the treatment of Parkinson’s disease patients, including Seal Rock Therapeutics’ brain-penetrant LRRK2/ASK1 signaling complex (LASC) inhibitors.
Seal Rock’s LASC inhibitors are first-in-class oral molecules that act by simultaneously blocking both LRRK2 and ASK1 to optimise efficacy.
Seal Rock’s LASC inhibitors have demonstrated powerful neuroprotective effects in preclinical studies.
Inhibition of both targets in tandem is more effective than targeting either alone and eliminates the kidney and lung toxicity exhibited by many LRRK2 inhibitors.
Neil McDonnell, CEO of Seal Rock Therapeutics, said: “Seal Rock is honoured to be a new industry member of The Michael J. Fox Foundation’s LITE programme and be part of a powerful consortium of academic and industry leaders who recognise the potential of LRRK2 inhibition for Parkinson’s disease.
“MJFF’s recognition of the need for collective action and the support to pursue this promising target is a bold step that will likely shave years off the time it takes for new drugs to be available to patients.”
“As for our programme, we are excited to learn more about LASC inhibitors through research by some of the top labs in the field. ASK1 and LRRK2 are central to many disease processes in Parkinson’s disease.
“Through the LITE initiative, we expect to gain a better understanding of their disease activity when both are inhibited simultaneously, as well as further exploring the mechanisms behind the elimination of kidney and lung safety findings.”
Shalini Padmanabhan, PhD, MJFF’s senior vice president and head of translational research, said: “We look forward to advancing what’s possible in LRRK2 drug development while de-risking industry investment through open-science policies and the collaboration of experts across key opinion leaders, including through the participation of Seal Rock Therapeutics.”
Novel gene therapy for ALS cleared for global trials in China
SineuGene Therapeutics has announced that China’s National Medical Products Administration (NMPA) has cleared the Investigational New Drug (IND) application for SNUG01.
The drug is a gene therapy product for amyotrophic lateral sclerosis (ALS).
This milestone follows a prior clearance of SNUG01’s IND application by the U.S. Food and Drug Administration in March 2025, paving the way for the initiation of a Phase I/IIa multi-regional clinical trial in both China and the United States.
SNUG01 is a first-in-class recombinant adeno-associated virus serotype 9 based gene therapy product that expresses the human TRIM72 protein, a new drug target for ALS initially identified and characterized by Dr. Yichang Jia’s group at Tsinghua University, upon delivery to the central nervous system (CNS), particularly motor neurons.
This global Phase I/IIa trial will evaluate the safety and potential efficacy of SNUG01 and identify dosage for further clinical development in adults with ALS.
The regulatory clearances that have been conducted in both the U.S. and China, demonstrating the momentum behind SNUG01’s global development.
Through strategic collaborations and scientific rigor, SineuGene is advancing its first-in-class gene therapy to address the unmet and urgent needs of the global ALS community.
MedRhythms appoints Larry Jasinski as CEO
MedRhythms, which is developing next-generation neurotherapeutics to improve walking, mobility and related functional outcomes, and creator of the world’s first prescription music platform, has announced the appointment of Larry Jasinski as CEO.
Co-founder of MedRhythms, Brian Harris, will transition to the role of Chief Scientific Officer (CSO) and work with Larry to build the market and grow the company in its next phase.
MedRhythms says that Jasinski brings more than three decades of executive leadership in the medical device and neurotechnology industries.
Most recently, he served as CEO of Lifeward, formerly ReWalk Robotics, where he led the company through a successful IPO and secured national reimbursement for the first exoskeleton system for spinal cord injury.
Prior to that, he was President and CEO of Soteira, which was acquired by Globus Medical in 2012.
MedRhythms says that Jasinski’s appointment marks a critical inflection point as the company prepares for national expansion of its home-use products for walking impairments: InTandem, for chronic stroke, and Movive, for Parkinson’s disease.
Both products are FDA-listed, Class II devices and are now available for federal healthcare distribution.
As CEO, Jasinski will lead MedRhythms’ strategic expansion, accelerate market adoption and build on its robust clinical foundation to bring the company’s platform to more patients with chronic health and mobility conditions.
Brain Injury Association of America to honour Dr. Mark Ashley as Luminary of the Year
The Brain Injury Association of America (BIAA) will honour Dr. Mark J. Ashley, founder and executive chairman of the board for the Centre for Neuro Skills (CNS), as Luminary of the Year.
The annual award celebrates the person who has made outstanding contributions to improving the quality of care, professional training, and/or education in the field of brain injury in their career.
“Creating a world with freedom and choices for people affected by brain injury has been my life’s purpose and sole focus for 45 years,” said Dr. Ashley.
“BIAA’s tireless advocacy ensures that brain injury survivors will always be seen, heard and prioritised. Their work is crucial to maintaining our collective momentum towards a better future for everyone affected by brain injury.”
“Dr. Mark Ashley’s contributions to the field of brain injury rehabilitation have been transformative,” said Rick Willis, BIAA’s president and CEO.
“Through his decades of leadership, innovation, and unwavering dedication to patient outcomes, he has raised the standard of care and expanded access to life-changing treatment.
We are proud to recognise Dr. Ashley as our Luminary of the Year and honour the profound impact he has made on survivors, families, and professionals across the country.”
Dr. Ashley founded CNS in 1980 after his brother, Steve, was left completely disabled, suffering from locked-in syndrome, cognitively intact but dependent on a ventilator, unable to move his body, speak or even breathe on his own.
Conventional medicine and available rehabilitative therapies gave his brother little hope for significant recovery or regaining his independence.
Dr. Ashley believed that Steve could overcome the odds and that rehabilitation was possible through an intense therapy programme.
His brother became one of CNS’ first patients, and his recovery became the model for the brain injury rehabilitation provider’s philosophy: patients don’t plateau.
In addition to his work at CNS, Dr. Ashley established the Clinical Research and Education Foundation, a nonprofit research organisation that advances public and clinical understanding of brain injury causes and treatment in 2011.
He has served on numerous committees and boards for organisations focused on brain injury treatment, research, and outcomes.
His work has been published in several professional and research publications, and he is the author of four books.
