BIOFEST INVEST APPLICANT
VIVIFI MEDICAL, INC
Legal Entity Type: C-Corp
Company Type: Medical Device
Company Stage: Development
No. of Employees: 2
Desired Financial Amount: $1.5M of $3M
When we came across research that showed that Varicocele (when gonadal vein becomes varicose) causes BPH, we started digging further. We realized two things: 1. varicocele is associated with a lot more than just BPH (including male infertility, low testosterone, erectile dysfunction – all $B markets), and 2. the current way to treat varicocele did not make logical sense. We proposed a new procedure and then found that someone had already done the procedure in 1984, but needed the right technology for clinical adoption. Immediately, we knew that we were onto something big. The founder believes that the technology will disrupt the way all of these conditions are treated, providing benefit to millions of patients around the world.
Our team includes experienced medtech executives in both startup and corporate settings. Our team has been involved with the launch of several early-stage medical device companies: Tushar Sharma, PhD (CEO) 10+ yrs exp across medtech startups and large corporations Frida Montoya (Sr. R&D Engineer): Biomedical engineer with past experience at Johnson & Johnson Medtech Nathan Starke, MD (CMO): urologist at Houston Methodist Hospital, expert in BPH, laparoscopic and robotic surgical technologies
Board of directors
William Cohn, MD – Cardiothoracic surgeon, serial entrepreneur with 4 acquisitions totaling >$1B Stan Rowe – Inventor or the TAVR, market cap >$8B Giovanni Lauricella – GP at Lifeblood Capital
Product / Service
disease area / application
Benign Prostate Hyperplasia (BPH)
product / Service
Problem | Benign Prostate Hyperplasia (BPH) is a massive problem affecting over 40 million men in the US alone with a market cap of $27B Solution | BPH can be reversed by minimizing testosterone exposure to prostate through redirection of testosterone-rich testicular blood away from the prostate. This is achieved by replumbing the pelvic vasculature via vascular anastomosis. Our first-of-its-kind medical device technology performs just that through a small incision. Our technology is the world’s first and only medical device solution for connection of two blood vessels using a laparoscopic approach. Advantage | 12M+ men are currently under treatment for BPH in the US alone. All existing treatments have up to 50% recurrency & provide temporary symptomatic relief only (nocturia). With lengthy recoveries, patients are left vulnerable to pain & discomfort from urinary catheters, hematomas, burning sensation while urinating & high risk for infections, UTIs. Additionally, these treatments lead to sexual complications such as ejaculatory & erectile disfunction. BPH can be reversed by minimizing prostate’s exposure to testosterone, redirecting testosterone-rich blood away from the prostate. This procedure does not result in any sexual or urinary complications. Therefore, provides massive value for the patients.
technology / ip
Our technology is the world’s first and only medical device solution for the connection of two blood vessels using a laparoscopic approach. Currently, the only way to connect two blood vessels in a MIS approach is by suturing, using a surgical robot. Suturing of blood vessels takes a long time and robotic procedures are very expensive. Vivi’s technology is easy to use, providing a low learning curve for adoption by Urologists and Surgeons; affordable with a short path to market (510(k)), and for patients, provides a long-lasting therapeutic effect due to a robust and durable vascular connection.
Vivifi will employ a distribution model, selling directly to large hospital institutions & private urology clinics. Our go-to-market strategy involves developing an internal sales force and engaging with established medical device distributors, forming strategic partnerships with large medical device companies to leverage preexisting, mature distribution channels with hospital GPOs (General Purchasing Organizations) and VACs (Value AddCommittees). Our preliminary analysis of the reimbursement landscape suggests potential for coverage of our technology under existing CPT codes for venous anastomosis (CPT code: 34520), reimbursing physicians 3x the amount of the leading treatment option (TURP) giving significant incentive for adoption.
In the US alone, there are over 12M actively managed BPH patients, and over 500k BPH surgeries performed each year. An estimated another 750k BPH surgeries are performed OUS each year. Based on comparable devices in the eld, we anticipate our device to sell for $2,500. This represents an obtainable market of over $3B
Direct: Baxter (acquired Synovis GEM Coupler) Indirect: Surgical robotic companies (Intuitive, Medtronic, J&J). Other: All major players in urology could become eventual competitors (Boston Sci, Olympus, Karl Storz, Braun, and Cook Medical) Competitive advantages: Presently, performing a vascular anastomosis is a highly challenging procedure that requires both extensive surgical training & expensive medical equipment. Due to the lack of dedicated medical devices available, physicians are limited to inadequate surgical tools or manual surgical techniques, resulting in long surgery times, high patient costs, and poor outcomes. Our technology allows for quick, easy, and reliable anastomosis with our disposable, MIS solution.
Desired financial amount
$1.5M of $3M
$35k Founders funding and Angel investors $50k SAFE M1 Medtech Accelerator $270k Non-dilutive capital; including NSF SBIR Phase I, SBA PPP and SWPDC Grant $1.5M NSF Phase II/IIb SBIR award (Dec 2022)
Burn rate: $14,000/month Current cash: $1M
Cadaver Studies Q3, 2023 Chronic Animal Studies Q4, 2023 Design Freeze, Q4, 2023 OUS Clinical study in 20 patients Q2, 2023
Our preliminary analysis of the reimbursement landscape suggests potential for coverage of our technology under existing CPT codes for venous anastomosis (CPT code: 34520), reimbursing physicians 3x the amount of the leading treatment option (TURP) giving significant incentive for adoption.
Acquisition is the primary exit strategy – we are working with strategic partners and continue to keep alignment with what they are looking for from us. Backup strategy would be IPO by raising our internal sales team.