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Jun 14, 2024

Weekly Recap 6/14/24: LSI Alumni Achievements Driving Medtech and Healthtech Forward

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This week, the top medical device companies in the the LSI Alumni community raised over $100 million in funding, won FDA IDE approvals, formed new strategic partnerships, and much more on the road to LSI Europe '24 in Sintra, Portugal this September. Here’s a look at the latest updates from LSI alumni making medical device news headlines.

Acarix

Acarix has announced the enrollment of the first patient in its initial US-based clinical study. This study aims to gather real-world data to compare workflows between traditional stress tests and the CADScor System. The CADScor System is designed for patients experiencing chest pain with suspected coronary artery disease (CAD) and aims to reduce millions of unnecessary, invasive, and costly diagnostic procedures.

Amber Therapeutics

Amber Therapeutics has successfully closed a $100 million Series A funding round. This funding will advance their breakthrough Amber-UI neuromodulation therapy for mixed urinary incontinence towards US FDA approval. The round saw participation from LSI Alumni including New Enterprise Associates, F-Prime Capital, Lightstone Ventures, Intuitive Ventures, and Oxford Science Enterprises, as well as 8VC.

Cala Health

Cala Health has announced the appointment of Deanna Harshbarger as Chief Executive Officer and as a member of the Company's Board of Directors. Additionally, Founder Kate Rosenbluth has been appointed as President and Chief Innovation Officer and will continue to serve on the Board of Directors. The company also announced that its TAPS Therapy is now covered by Medicare for essential tremor patients.

Lazzaro Medical

Lazzaro Medical has been awarded a $2.4 million SBIR Phase II grant from the National Heart, Lung, and Blood Institute (NHLBI) of the NIH. The company aims to restore healthy breathing in millions of people suffering from tracheal and bronchial maladies through its transformative platform of minimally invasive robotic procedures, devices, and diagnostics.

MEXBRAIN

MEXBRAIN has announced the start of a second clinical trial focused on Acute-on-Chronic Liver Failure (ACLF). The company develops innovative medical devices that combine chelating biopolymers and hemodialysis technology aiming to rapidly and safely extract toxic metals from the blood.

MIMOSA Diagnostics

MIMOSA Diagnostics has successfully closed its latest round of financing. This round was led by Kern Venture Group, Kindling Investment Partners, Spring Impact Capital, Raspberry Investments Corporation, and Mimosa Partners, along with returning investors Archerwill Investments and the XDL Group. MIMOSA’s proprietary platform aims to enable real-time, point-of-care assessment of tissue health, providing unprecedented insights and early detection capabilities.

SafeHeal

SafeHeal has received FDA Breakthrough Device Designation to investigate the use of Colovac™. Colovac is intended as an alternative to temporarily diverting ostomy for patients undergoing colorectal resection.

Sinaptica Therapeutics

Sinaptica Therapeutics has announced a signed Letter of Intent for manufacturing collaboration with Nextstim. Nextstim will exclusively collaborate with Sinaptica to develop, manufacture, and supply Sinaptica’s patented precision neuromodulation system, custom-based upon the Nexstim NBS 6 system, with its advanced TMS-EEG and precision neuronavigation capabilities, for treating Alzheimer’s Disease.

Sterile Processing Express (SPDx)

Sterile Processing Express (SPDx) has received an Advanced Sterile Processing Certification from DNV GL. SPDx provides comprehensive sterile processing and logistic support, aiming to enable increased surgical volume and compliance without capital risks.

THINK Surgical

THINK Surgical has entered into a limited exclusive distribution and supply agreement with Zimmer Biomet. This agreement will result in an exclusive offering that integrates Zimmer Biomet technology into a customized TMINI® robotic solution for total knee arthroplasty.

TibaRay

TibaRay has entered into a partnership with Leo Cancer Care to co-develop a next-generation upright linear accelerator. TibaRay’s mission is to create breakthrough technologies to bring the hope of cure to patients with all types and stages of cancer, worldwide.

Vessi Medical

Vessi Medical has announced the appointment of LSI Alumni Christos Monovoukas as the new Chairman of the Board. The company uses surface cryotherapy in the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).

Xeltis

Xeltis has received FDA IDE Approval for the initiation of a US pivotal trial for aXess. The company is developing transformative vascular implants that enable the natural creation of living and long-lasting tissue.

Stay tuned for more updates as medical technology companies and investors like these continue to innovate and lead the way in the medtech industry.