The Weekly Recap 4/11/25: LSI Alumni Achievements Driving Medtech and Healthtech Forward

In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni secure regulatory approvals, launch new products, secure new funding, and much more on the road to LSI Asia ‘25 in Singapore (June 10-13).

4D Biomaterials

Achieved ISO 13485 certification, the globally recognized standard for quality management systems for medical devices. The accreditation strengthens the company’s manufacturing readiness for its 4Degra bioabsorbable resin platform, supporting its commercial strategy and accelerating regulatory pathways toward clinical deployment.

ANEUVO

Secured CE Mark certification for the ExaStim® Stimulation System, validating its safety and performance under Medical Devices Regulation (EU) 2017/745. The approval, alongside ISO 13485 compliance, enables European market entry and reflects ANEUVO’s commitment to advancing non-invasive therapies for individuals with chronic spinal cord injury.

Brainomix

Received FDA clearance for a novel feature of Brainomix 360 that enables ischemic core volume assessment using standard non-contrast CT scans. The advancement expands access to life-saving stroke treatments, reinforcing Brainomix’s mission to democratize expert-level imaging insights and improve outcomes across stroke networks.

Cala Health

Presented new clinical data at the American Academy of Neurology (AAN), demonstrating that consistent use of Cala TAPS™ Therapy reduces tremor severity, modulates key brain networks, and reduces ET-related healthcare costs. The findings further strengthen Cala Health’s position as a leader in wearable neuromodulation for essential tremor, backed by robust evidence from over 2,000 patients.

Caretaker Medical

Received the inaugural Healthcare Technology Innovation Award and a $200,000 grant from the Medical Society of D.C. for its FDA-cleared VitalStream platform. The recognition highlights Caretaker Medical’s leadership in wireless, continuous blood pressure and hemodynamic monitoring, supporting both everyday care and crisis response.

Elixir Medical

Received CE Mark approval and launched the LithiX™ Hertz Contact (HC) IVL System in Europe, marking the debut of a novel mechanical intravascular lithotripsy platform. The approval strengthens Elixir Medical’s coronary portfolio and enables broader treatment of calcified lesions with a wire-free, energy-independent approach.

GT Medical Technologies

Launched the GammaTile® Center of Excellence Program and designated the USC Brain Tumor Center as its first COE site. The program recognizes leading institutions advancing care for operable brain tumors through clinical expertise, education, and adoption of GammaTile’s targeted intraoperative radiation therapy.

HighLife

Received FDA Breakthrough Device Designation for its trans-septal mitral valve replacement (TMVR) system. The designation supports HighLife’s path to U.S. market approval, recognizing its potential to transform care for patients with moderate to severe mitral regurgitation.

iCAD

Appointed LSI Alumni Mark Koeniguer as Chief Commercial Officer to lead global revenue growth and commercial operations. Koeniguer’s extensive experience in medtech, AI, and medical imaging strengthens iCAD’s position as a leader in radiological AI and breast cancer detection.

Nia Therapeutics

Appointed renowned memory scientist Prof. Michael Kahana as CEO to lead the development of closed-loop neurostimulation therapies. His foundational research in human memory and brain-computer interfaces strengthens Nia Therapeutics’ mission to treat memory loss from traumatic brain injury and other neurological conditions.

NovApproach Spine

Partnered with Lovell Government Services to provide the OneLIF™ spinal fusion system to federal healthcare systems such as the Veterans Health Administration (VHA), the Military Health System (MHS), and the Indian Health Service (IHS). The agreement expands access to NovApproach Spine’s versatile interbody device while supporting SDVOSB procurement goals and improving care for veterans and military patients.

OSSTEC

Raised £2.5M to support the market launch and scale-up of its advanced orthopedic implants. The funding accelerates Osstec’s mission to transform joint replacement with its 3D-printed implants that combine biomimetic design and cementless fixation for better outcomes and faster recovery.

Proprio

Received a second 510(k) clearance from the FDA for Paradigm to include intraoperative measurements. This milestone enables real-time, radiation-free surgical assessment and reinforces Proprio’s position as a global leader in AI-driven surgical technology.

Sinaptica Therapeutics

Announced two major milestones supporting the commercialization of its personalized rTMS-EEG therapy for Alzheimer’s disease. The CPT Editorial Panel voted to establish two proprietary Category III codes specific to Sinaptica’s proprietary approach, establishing a reimbursement pathway; meanwhile, new 52-week Phase 2 results published in Alzheimer’s Research & Therapy showed significant slowing of disease progression with no serious side effects.

SOMAVAC

Closed $1.2M within a week of announcing its $3M Series A raise, signaling strong investor confidence in its post-surgical drain management solution. SOMAVAC is reporting commercial traction in Houston, Denver, San Antonio, North Carolina, Tennessee, and Ohio, and is actively hiring sales professionals to support its growth in these markets.

Vektor Medical

Achieved ISO 27001 certification, aligning its information security practices with global standards for data protection and risk management. The milestone reinforces Vektor Medical’s commitment to security as it advances toward CE Mark approval in 2025.

Xeltis

Successfully passed the evaluation phase for a €10M equity investment from the European Innovation Council’s STEP Scale-Up call program. The funding will support Xeltis’ commercialization efforts for its bioresorbable vascular conduit, aXess™, as the company prepares for pivotal trial readouts and market entry.

Stay tuned for more updates, insights, and achievements of our LSI Alumni in The Weekly Recap, and follow our blog for the latest medical device news and advancements.