BoneChat скачать в хорошем качестве

BoneChat

n this episode of BoneChat (#111), host Tiger Buford welcomes Chance Leonard (CEO) and Dr. Sean Churchill to discuss Capitan Orthopedics, a startup focused on treating irreparable rotator cuff tears. The presentation introduces the Super Spacer, a cobalt-chrome implant designed to fill the clinical gap for patients (typically aged 35–60) who are too young for a reverse shoulder arthroplasty but have failed traditional repairs. Key Highlights The Problem: Over 700,000 rotator cuff surgeries are performed annually, but failure rates for massive tears are high (up to 94% in some studies) [06:03]. Patients are often left with a "proximally migrated" humeral head that rubs against the acromion, causing debilitating pain and loss of function [09:41]. The Solution (Super Spacer): Unlike temporary balloons or biologic grafts, the Super Spacer is a permanent metal implant that acts as a cam mechanism [22:20]. It retensions the joint, pushes the humeral head down, and restores the "deltoid wrap" to allow for better leverage and movement [21:20]. Surgical Efficiency: Designed for ease of use, the procedure involves a 3cm "mini-open" approach and just seven surgical steps [26:30]. The implant is sterile-packaged and side-agnostic (no left/right specific parts), making it ideal for Ambulatory Surgery Centers (ASCs) [27:02]. Rehabilitation: Because the procedure doesn't rely on tendon-to-bone healing, patients can often begin range-of-motion exercises immediately, with a goal of returning to unrestricted activity by six weeks [36:32]. Q&A Insights Market Opportunity: The team estimates a conservative market of 200,000–250,000 potential candidates per year [25:01]. Regulatory Path: Capitan is pursuing a 510(k) pathway with a confirmed predicate device. They are currently in the verification and validation phase, targeting a Limited Market Release (LMR) in Q4 of 2024 [33:10]. Future Planning: Dr. Churchill emphasizes that the Super Spacer does not "burn bridges" [17:31]. If a patient eventually needs a reverse shoulder replacement 15 years later, the implant can be removed easily, leaving the bone in a state similar to a primary surgery [19:39]. Company Status: Capitan Orthopedics has already raised $1.275M of its $2M seed round to fund the first 100 clinical cases [43:59].