MIPS Project Detail:

Sonavex, Inc.

EchoMark Pivotal Safety & Efficacy Porcine Study

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Company

Sonavex, Inc.

Baltimore

Baltimore City

County

, Maryland

Founded:

2014

Website:

https://www.sonavex.com/

Company Description:

Sonavex Inc. is a medical device company spun out of Johns Hopkins. The company is dedicated to providing novel ultrasound solutions to visualize and quantify critical data for improved outcomes and reduce costs in new surgical applications. Sonavex developed EchoSure to detect blood clots after surgery to prevent catastrophic surgical failures.

MIPS Project

EchoMark Pivotal Safety & Efficacy Porcine Study

Project #

5826

|

MIPS Round

58 |

Starting Date:

Aug 2016

MIPS Project Challenge:
The purpose of this MIPS project was to conduct a pivotal animal study that would show not only the EchoSure device performance, but also prove that the device is safe for in vivo use. The results of the study would enable Sonavex to submit a data package to the FDA for 510(k) clearance of the device and approval for sale.

Project Scope:
For this MIPS project, researchers were slated to conduct a twelve-month, in vivo survival study where the EchoMark is implanted. A control arm with sham surgery will also be conducted. Ultrasound evaluations will evaluate the echogenicity of the marker. At the study end, histology will be performed to show that the marker has not induced any adverse changes in the animal, either locally or systemically.

Results:

In April, 2017, Sonavex announced that it received $3 million in financing, including the $2.2 million first close of its Series A round. The offering, led by Grey Sky Venture Partners, was expanded by another $1.3 million following increased demand from investors. Other participating investors included CRCM Venture Capital, TEDCO, the Abell Foundation, medical device executives, surgeons and successful business executives.

The company has also secured grants from TEDCO, NIH SBIR, NSF SBIR (Phase I, Phase IB, Phase II), and several competition awards.

Sonavex was named a Maryland 2016 Incubator Company of the Year.

Additional Information:
More than 550,000 procedures each year in reconstructive, transplant, and vascular surgery involve a connection of blood vessels that is necessary to provide blood flow to downstream tissue. Invariably, there is a risk of clot formation. Detecting clot formation in a timely manner allows intervention to remove the clot before it permanently blocks the vessels and is key to preventing catastrophic and expensive surgical failures.

Due to limitations of current modalities, routine monitoring occurs only in the plastic surgery (reconstruction) market, where up to 15 percent of cases will require emergency salvage for clot formation. Delays associated with current monitoring techniques result in a ~50 percent failure rate for salvage attempts. The non-reimbursed financial loss for a hospital ranges between $57,000 and $577,000 per instance, depending on the surgery. (Source: Sonavex)