Bradley Beach Presents Covellus at LSI USA '23

Transcription

Bradley Beach  0:04  

Bradley Beach, pleasure to be here. I am the CEO and founder of Covellus, developer of the only multifunction modular catheter system. So with multifunction modular catheter systems helps all stakeholders do more with less and that means for physicians more case, more productivity, like an extra case per day. For hospitals, it's less inventory. For manufacturers, it's more sales opportunities and ultimately, better care for patients. Initially, Covellus is a developing modular systems for peripheral artery disease, which impacts 250 million people. balloon catheters are the backbone of endovascular treatments as as worth $2.9 billion globally. Now they come in many balloon types. Each balloon type combines an inflatable balloon with other functions and features like rapid exchange scoring, drug coatings, high pressure, even calcium fracturing lithotripsy however, with conventional catheters, each balloon type requires many dozens or even hundreds of stock keeping units. This is to accommodate the range of diameters and lengths needed for endovascular procedures. Now, this conventional, the conventional catheters, the skew complexity associated with conventional catheters means more catheter products have to be stored outside the operating room. So when a doctor since rolling his devices, and procedure stops, and everyone's just waiting, think of a mechanic under a car, their tools aren't at arm's reach, they gotta send someone to find it. Additionally, conventional carriers have no versatility to be adapted to fit the procedure. For device company, the high cost to develop, manufacture and inventory these large SKU product lines, limits what can be pursued and the number of products available. Our solution is a modular architecture that limits this SKU complexity to a single balloon type. The Covellus o 35. Parent balloon, under balloon types are created by adding a single SKU COVID Plus adapter, adding functions and features in the form of a single SKU Cabelas adapter. To create a new balloon type, the doctor inserts the coils adapter into the distal of the parent balloon. Adding that functionality feature like back when a guide lawyer the new balloon type is ready to use just like a conventional catheter. This is analogous to modular screwdrivers where one handle equals many products. These endovascular procedures are complicated with lots of steps involving many catheters and guidewires. To get the desired therapeutic result, there are modular approach. Physicians can adapt their capture tools to fit procedure, combining functions and eliminating procedure steps. The conventional catheter away the old way is, is the doctor has to adapt the procedure to fit the tools. Now, think about that doesn't that sound backwards? Additionally, more capital products can be kept at arm's reach in the operating room with less waiting around. For manufacture. Modularity shortens the timeline between a product concept and a product launch. We're developing a Cobos parent balloon and seven adapters to create the proprietary modular balloon system. The seven adapters are mix of common balloon types, and high margin time saving products. The plan is to gain 510 K clearance, initiate an production manufacturing and initiate early sales. Batchelor closure devices multifunction scalpels and surgical staplers are all examples of adoption because of time saving attributes. These technologies were developed to make doctors more productive and are now standard practice. The high pressure balloon adapter is an example of combined functionality to eliminate procedure steps and save time. Conventionally, this requires two catheters and two procedure steps. With the Cabella solution. This is a combined into one catheter and only one step. The eye Val adapter is similar adding lithotripsy to any parent balloon to treat vascular calcium. Vascular Calcium is a challenge in many PhD cases, often resulting in sub optimal angioplasty. intravascular lithotripsy, or IBL was effective at preparing calcified arteries for ballooning and recently received increased Medicare reimbursement. This incentive aligns with the need for more efficient IBL products. Currently, there's only one IV l product available. The IBL adapter closes developing the IBL adapter to address faster calcium. The adapters added to any parent balloon To create an IPL solution, our modular approach packages electrohydraulic lithotripsy or EHL technology into the adapter to deliver calcium fracturing shockwaves. Each l technology has been used for 40 years to fracture calcium obstructions like kidney stones, biliary stones, and vascular calcium. This creates a multifunction solution delivering shockwave energy while crossing the lesion followed by long ballooning after. As a case study, to demonstrate the feasibility of our modular approach, we developed a scoring adapter for veterinary use. This was used to successfully use the Create a 12 millimeter scoring balloon from an existing commercial 12 millimeter balloon at the point of care during a canine pulmonary valve neoplastic procedure, essentially, during a commercial blown into a scoring blown with one SKU Cabela's has met with the FDA several times. Our modular approach is as low risk and streamlined way to use accessory classification to create new Catherine products. With the accessory classification. The parent catheter is the predicate device, and adapters are classified according to their risk alone not that of the parent. For example, a class two adapter can be approved for use with a class three stent. This creates opportunities for Industry Collaboration, for example, code development of adapter designs using existing older refined devices like stents, stent grafts and balloons as the parent catheter our modular architecture is protected by 120 claims from seven pans plus to more recent adapter specific patent applications. I have an extensive background in medical device development including inventing and femoral popliteal stent was acquired by j&j Cordis. I started develops because I truly believe a modular approach can impact our industry in a meaningful way and it needs to exist. I started this journey alone, but along the way, I found many others who also believe modular catheter systems need to exist. My advisors are key opinion leaders understand how it'd be used to address pain points and create efficiencies. I also have a background in manufacturing catheter products including cofounding magic medical and 2012 Magic medical is ISO 1345 certified based in Hyderabad, India and provides contract manufacturing and development services. Magic medical is Cobell is his manufacturing and development partner. Many companies offer balloon products among these competitors, balloon products are largely undifferentiated the coverless modular balloon system is a category unto itself. We are seeking investment partners to raise $7.7 million to develop the initial proprietary modular balloon system, implement commercial manufacturing and initiate early sales and use. The goal is to create a pipeline of products that will be quickly a creative on plugged into existing sales channels of strategic partners. For this reason, Cobalt is a likely acquisition candidate. Many companies continue to invest in endovascular therapies, and would also have interest in folding the modular balloon system into their sales channels. While oh three five parent devices are a good way to start there. It's an artificial constraint which when removed would allow the development of smaller below the knee and coronary systems. Other advancements including cool including include packaging other device technologies like IVs, or drug delivery technologies into CO Bellis adapters. I've done a lot with a little and I'm looking for partners so I'm looking for partners that also want to also believe that modular capture systems need to exist thanks for your time.