DurVena is commercializing a novel photochemical tissue passivation therapy to strengthen vein grafts, improve long term graft patency, and address this unmet $6B clinical opportunity for patients undergoing CABG, PAD, and AVF surgeries.
Danville, CA, USA
One Liner
One Liner
DurVena is commercializing a novel photochemical tissue passivation therapy to strengthen vein grafts, improve long term graft patency, and address this unmet $6B clinical opportunity for patients undergoing CABG, PAD, and AVF surgeries.
What Problem We are Solving
Problem
Over 1 million Coronary Artery Bypass Graft (CABG), Peripheral Artery Disease (PAD), and Arteriovenous Fistula (AVF) procedures are performed in the U.S. annually. These procedures utilize the patients vein as a new graft for arterial blood flow. Structurally, veins are not designed to withstand arterial pressure. The vein grafts expand under the arterial pressure and are subject to reported degeneration and occlusion rates from 15-25% in the first year and as high as 50% at five years. Vein graft failure is associated with a significant increase in major adverse cardiovascular events (MACE), including death, myocardial infarction (MI), and the need for expensive and risky repeat revascularization.
About Us
About Us
DurVena has an exclusive worldwide license to this novel therapy from Mass General Hospital and is founded and managed by an accomplished team of business professionals with several successful exits ($1.25B in total investor returns) and extensive experience with start-up medical device development in this market sector. Broad claims covering the PTP method and devices for vein graft preparation have been issued around the world, and a several peer-reviewed pre-clinical papers showing the effects of PTP have been published by top medical journals.
Venture Highlights
Highlights
5 published pre-clinical peer reviewed journal articles 13 patents issued Scientific Advisor Board of 6 KOLs Prototypes completed and tested
Business Model
Business Model
As a medical device company our business is driven by clinical data and regulatory approvals. We plan to start our first in human clinical trial outside the US in 2023. We will collect the data from that in early 2024 which will create an inflection point for the company to raise a Series A (~15M). With the Series A funding, we will conduct and complete our U.S. FDA clinical trials and obtain PMA approval. We will present the clinical data at medical conference and publish in in medical journals. This will drive our sales directly to hospital customers as requested by the cardiothoracic surgeons. We will also pursue a Breakthrough Device Designation from the FDA. This designation will enable us to able for a New Technology Add-on Payment from CMMS. The payment will reimburse hospitals for purchasing our technology so that there will be no impact on their profits. We will have an internal sales management team and sell through a combination of direct sales force and contracted distributors.
Competitive Advantage
Quote
Over 100 years of experience developing and commercializing new medical technologies.
8 exits (including 2 IPOs) that returned over $1.25B to investors
Unmet clinical need that represents 3 distinct large market opportunities.
Raised $5M to date (only 20 investors)
5 US and 5 OUS patents issued many more applications in process
5 published peer-reviewed preclinical papers
Strong SAB with KOLs from top academic centers
Revenue
Revenue To Date
N/A
MRR
N/A
Revenue YTD
N/A
Burn Rate
$200K
Customer Costs
CAC
N/A
LTV
N/A
Churn
N/A
Margins
95%
Go-To Market Strategy
Business Strategy
Publish/present clinical trial results in top journals and medical conferences
Utilize internal sales management and combination of direct and contract regional sales representatives
Obtain CMMS New Technology Add-on Payment for reimbursing hospitals for our product.
There is no competition for improving autologous vein graft durability and longevity. Our product is better as it uses the patient's own veins which are significantly less likely to cause infections (such as artificial grafts used instead of AV Fistulas for hemodialysis patients (and are only used after all AV Fistula options are exhausted).
New emerging artificial grafts will require very long term clinical trials (5 yrs) and will be much more expensive (Xeltis). As well no artificial graft the size needed for CABG and PAD has ever maintained patency in clinical trials for over 1 year.
We are open to meeting up to grab a coffee, or just to chat.
We would really enjoy your feedback and insight into our venture and would be happy to discuss anything that you are currently working on to see if we can be of service!
