MedTech Startup Roundup – Vol.2 No.10

Acquisition
Xtant Medical: Implant, Spine Surgery, Orthobiologics – Belgrade, MT
Companion Spine: Implant, Spine Surgery – Mérignac, France

Xtant Medical Finalizes Companion Spine Transactions

The Cs

Elutia: Implant, Mesh, Antibiotic-Eluting, Plastic and Reconstructive Surgery – Gaithersburg, MD

Pete Ligotti – CCO (Joining)

Elutia Selects Pete Ligotti as CCO to Lead the Commercial Launch of NXT-41x and Transform Post-Mastectomy Care in the $1.5B U.S. Breast Surgery Market

VDyne: Implant, Transcatheter, Heart Valve – Maple Grove, MN

Mike Buck – CEO (Joining)

VDyne Appoints Mike Buck as Chairman and CEO to Lead Next Phase of its TTVR Program

Board Members

Shoulder Innovations: Implant, Orthopedic – Holland, MI

Drew Hykes – Board Member (Joining)

Shoulder Innovations Appoints MedTech Veteran Drew Hykes to Board of Directors

Valcare Medical: Implant, Procedural Device, THV, Interventional Cardiology – Herzliya Pituach, Israel

Jeffrey B. Jump – Board Member (Joining)
Jacques Séguin, MD, PhD – Board Member (Joining)

Valcare Medical Appoints Two New Members to Board of Directors

Funding

Ease Health: Soft/SaaS, EHR, CRM, RCM, Behavioral Health – New York, NY

Ease Health Emerges from Stealth with $41M from Andreessen Horowitz to Redefine the Operating System for Behavioral Health

Xsensio: Diagnostic, Lab-0n-Skin – Lausanne, Switzerland

Xsensio SA Raises $7M Oversubscribed Series A, Accelerates Clinical Deployment of Continuous Biosensing

Polares Medical: Interventional Device, Transcatheter, Heart Valve, Interventional Cardiology – Palo Alto, CA

Polares Medical Raises $50 Million Series C to Advance U.S. Expansion of MRace Following Strong Clinical Results

KeyCare: Soft/SaaS, Virtual Care – Chicago, IL

KeyCare Raises $27.4 Million to Scale their AI-Powered, Epic-Based Virtual Care Solution for Health Systems

UnityAI: AI, Agentic, Pt. Coordination – Nashville, TN

UnityAI Raises $8.5M to Expand an Autonomous AI Workforce for Healthcare Operations

Science Corporation: BCI, Ophthalmology, Neurology, Physical Med – Alameda, CA

Science Corporation Closes $230 Million Series C to Accelerate Commercialization of Its PRIMA BCI Retinal Implant, the World’s Most Advanced Vision Restoration Technology

Cognito Therapeutics: Wearable, Neuromodulation, Neurology, Alzheimer’s – Cambridge, MA

Cognito Therapeutics Announces Oversubscribed $105 Million Series C Financing to Advance Spectris™ in Alzheimer’s Disease

Regulatory

IDE
Ultrasound AI: AI, Soft/SaaS, Birth Date Prediction, Women’s Health – Highlands Ranch, CO

Ultrasound AI Receives FDA De Novo Clearance for Delivery Date AI Technology

Approval
Dxcover: AI, Liquid Biopsy, Oncology – Glasgow, UK

Dxcover Secures CE-IVDR Certification

Approval
Perimeter Medical: AI, Imaging, Diagnostic, Breast Cancer – Toronto, ON

Perimeter Medical Imaging AI’s ‘Claire’ Becomes First FDA-approved AI-Enabled Imaging Device for Breast Cancer Surgery

Approval
Harrison.ai : AI, Soft/SaaS, Imaging – Sydney, Australia

Harrison.ai Receives FDA Clearance for Acute Infarct Triage on Non-contrast CT Brain

Approval
Soterix Medical: Neuromodulation, Non-Invasive, Mental Health – New York, NY

Soterix Medical Announces Clearance of SPRY Transcranial Magnetic Stimulation (TMS) Therapy for the treatment of Major Depression

Approval
Liquet Medical: Diagnostic, Interventional, Hemodynamic Monitoring – Glen Allen, VA

Liquet™ Medical Receives Second FDA 510(k) Clearance for Versus™ Catheter

Product News

HeartBeam: DME, ECG – Santa Clara, CA

HeartBeam Announces First Commercial Customer as ClearCardio Brings Groundbreaking 12-Lead ECG Technology to High-Growth Preventive Cardiology Market

Mitria Medical: Implant, Minimally Invasive, Transcatheter Heart Valve Repair – Cleveland, OH

Mitria Medical Announces First Use of Novel Mitral Valve Repair Device in U.S. Under Single Patient Expanded Access

Breakthrough Devices

RecovryAI: AI, Soft/SaaS, Post-Op Virtual Care – San Francisco, CA

RecovryAI Announces FDA Breakthrough Device Designation for Patient-Facing Clinical AI

Airiver Medical: Procedural Device, Drug-Coated Balloon, Airway Stenosis, Interventional Pulmonology – Brooklyn Park, MN

Airiver Medical Granted FDA’s Breakthrough Device Designation for Pulmonary Drug Coated Balloon to Treat Central Airway Stenosis; First Patient Treated in Clinical Trial

Reimbursement

AIQ Solutions: Diagnostic, Precision Medicine, Oncology, Late-Stage – Madison, WI

AIQ Solutions Announces a New Category III CPT Code for Determining Heterogeneity of Change Across All Lesions for Advanced Metastatic Cancer Used with TRAQinform IQ Technology

Innoblative Designs: Procedural Device, Electro-Surgery, Breast Cancer – Chicago, IL

AMA Approves Category III CPT® Code for Innoblative’s SIRA® RFA Electrosurgical Device, an Adjunct for Patients Undergoing Breast Conservation Surgery

Clinical Trials/Studies

IceCure Medical: Procedural Device, Minimally Invasive, Cryoablation, Breast Cancer – Caesarea, Israel

IceCure Medical Reports Independent Study Published in PLOS One Demonstrating ProSense® Cryoablation Safe and Effective in Treatment of Breast Fibroadenomas

Sonex Health: Procedural Device, Minimally Invasive, Ultrasound-Guided, Orthopedic Surgery – Eagan, MN

MISSION REGISTRY DATA CONFIRM ULTRASOUND

Smart Meter: Remote Pt. Monitoring, Predictive Medicine – Tampa, FL

Landmark digiiMED Study in Puerto Rico Utilizing Smart Meter Cellular-Connected Devices Helps 54% of Uncontrolled Hypertension Patients Achieve Blood Pressure Control

Liberate Medical: DME, Respiratory Muscle Stimulator, Non-Invasive – Crestwood, KY

Liberate Medical Completes Enrollment of 250-Patient PREVENT Pivotal Trial Evaluating VentFree® Respiratory Muscle Stimulator

bioAffinity Technologies: Diagnostic Test, Liquid Biopsy, Oncology, Lung Cancer, Allergy – San Antonio, TX

bioAffinity Technologies Presents Positive Research Findings for its Novel Diagnostic Platform Technology to Identify Optimal Therapies for Asthma Patients

Relief Cardiovascular: Implant, Transvascular, Diagnostic, Therapeutic, CHF – Costa Mesa, CA

RELIEF CARDIOVASCULAR REPORTS POSITIVE FIRST-IN-HUMAN DATA FOR DEVICE-BASED DECONGESTION THERAPY IN HEART FAILURE PATIENTS

Adela: Diagnostic, Precision Medicine, Oncology – Foster City, CA

Adela Announces Study Published in NPJ Precision Oncology Clinically Validating its Tissue-Free Test to Monitor Immunotherapy Response in Advanced Solid Tumors

CereVasc: Implant, Shunt, Neurosurgery, Hydrocephalus – Charlestown, MA

First-in-Human Use of CereVasc® eShunt® System in Idiopathic Intracranial Hypertension Demonstrates Sustained Clinical Outcomes

Arsenal Medical: Procedural Device, Liquid Embolic, Foam Embolic, Neurovascular, Trauma Surgery – Waltham, MA

Arsenal Medical Announces First Patient Treated with ResQFoam for Life-Threatening Abdominal Bleeding

Airiver Medical: Procedural Device, Drug-Coated Balloon, Airway Stenosis, Interventional Pulmonology – Brooklyn Park, MN

Airiver Medical Granted FDA’s Breakthrough Device Designation for Pulmonary Drug Coated Balloon to Treat Central Airway Stenosis; First Patient Treated in Clinical Trial

HeartBeam: DME, ECG – Santa Clara, CA

HeartBeam Announces First Patient Enrollments in Heart Attack Detection Pilot Study

SimBioSys: 3D spatial visualizations, Breast Cancer – Chicago, IL

SimBioSys Highlights Clinical Data Demonstrating AI Digital Twin Performance Comparable to Radiologists at 43rd Annual Miami Breast Cancer Conference®

Viz.ai: AI, Soft/SaaS, Diagnostic, Oncology – San Francisco, CA

Viz.ai Study Demonstrates 44% Reduction in Interfacility Stroke Transfer Times

Neuspera Medical: Implant, Neuromodulation, Urologic Surgery, Urinary Incontinence – San Jose, CA

Neuspera Medical Announces 12-Month Pivotal Trial Results for the Company’s Integrated Sacral Neuromodulation System for Urinary Urge Incontinence

Partnerships

OpenEvidence: AI, Soft/SaaS, Clinical Information – Cambridge, MA
Wiley: Service, Content & Research – Hoboken, NJ

Wiley and OpenEvidence Partner to Deliver Trusted Research to Physicians at the Point of Care

OneStep: AI, Digital Medicine, Movement Sensor – New York, NY
Protonics: DME, Movement, Neuromuscular Re-Education – Lincoln, NE

OneStep and Protonics Announce Strategic Partnership to Create an Intelligent Movement Ecosystem

Lohman Technologies: RPM, ECG – Pewaukee, WI
Salvo Health: Virtual Care, GI – New York, NY

Lohman Technologies Announces Deeper Strategic Partnership with Salvo Health to Advance Comprehensive Remote GI Care

Patents

Delta Development Team: Blood Transportation & Warming – Tucson, AZ

Patent Award Marks Key Milestone for Delta Development Team’s Autonomous Portable Refrigeration Unit

Legal Battles

SkinCure Oncology: Radiation Therapy, Superficial, Skin Cancer – Burr Ridge, IL

SkinCure Oncology Seeks Federal Court Injunction to Cease Unlawful Effort to Strip Medicare Coverage for Image-Guided Superficial Radiation Therapy

ExThera Medical: Blood Filter, Infectious Disease – Martinez, CA

ExThera Medical Announces Resolution of Federal Investigation

This & That

Vicarious Surgical: Robotics, Surgical – Waltham, MA

NYSE to Commence Delisting Proceedings Against Vicarious Surgical Inc. (RBOT)

VentureMed Group: Procedural Device, Vascular Surgery – Plymouth, MN

VentureMed Group Announces It Is Now Doing Business as Flex Vascular

Datasea: AI, Robotics, Healthcare – Beijing, China

Datasea Accelerates Global Commercialization of Acoustic + AI Health Care Robots, Expanding Scalable Applications in China and International Markets

Distribution Agreements

Womed: Procedural Device, Intrauterine Adhesion Protection, Gynecology, Women’s Health – Montpellier, France
Karl Storz: Capital Equip, Endoscopes – Tuttlingen, Germany

KARL STORZ and Womed Announce Strategic Partnership to Distribute Womed Leaf in the United States

About Stiffler Search Group

Stiffler Search Group was founded in 2009 by Dan Stiffler, a seasoned veteran in medical industry recruiting. Our work is performed on retainer or contingency. We work with companies of all sizes, but our passion lies in representing early-stage MedTech companies, with a focus on procedural devices and capital equipment. If you would like to discuss a potential search, click here. If you would like to engage with us as a candidate, please submit your resume for consideration.

About MedTech Startup Roundup

We bring you the latest news on early-stage companies, people, and products driving innovation in the MedTech industry via the MedTech Startup Roundup. Our publication is a compilation of news from multiple sources, encompassing a broad range of topics. The focus is on North American companies. We also cover young, publicly traded companies and similar companies from other countries with business activities in North America. We hope you find it helpful and share it with your associates!

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