The incubator, PMX, and medical device firm
Hatch Medical, execute joint venture agreement to complete their
development and commercialization, starting with PortIO
NEW YORK, March 21, 2024 /PRNewswire/ -- PAVmed
Inc. (Nasdaq: PAVM) ("PAVmed" or the "Company"), a diversified
commercial-stage medical technology company, operating in the
medical device, diagnostics, and digital health sectors, today
announced that it has launched a wholly owned incubator, PMX, to
complete development and commercialization of existing portfolio
technologies, including the PortIO™ Implantable Intraosseous
Vascular Access Device ("PortIO"), EsoCure™ Esophageal Ablation
Device ("EsoCure"), and CarpX® Minimally Invasive Device
for Carpal Tunnel Syndrome ("CarpX"). PMX and Hatch Medical, L.L.C.
("Hatch Medical"), a medical device incubator and technology
brokerage firm with decades of experience successfully advancing
medical technologies and brokering strategic transactions, have
executed a joint venture agreement to advance the technologies.
"Since inception, PAVmed's corporate vision has been to build a
diversified medical technology company advancing a broad portfolio
of groundbreaking technologies to commercialization," said
Lishan Aklog, M.D., PAVmed's
Chairman and Chief Executive Officer. "Although we made the
difficult decision to pause these projects in early 2023 and focus
substantially all our resources on the near-term commercial
opportunities in our major subsidiaries, Lucid Diagnostics and
Veris Health, we continued to explore ways to revive their
development and commercialization. The PMX incubator is structured
to facilitate capital formation to do just that. We are thrilled to
join forces with the seasoned medtech veterans at Hatch Medical in
this venture and believe that this partnership gives these
groundbreaking technologies the opportunity to fulfill their
clinical and commercial potential, starting with PortIO."
Pursuant to the joint venture agreement, PAVmed will assign
PortIO, EsoCure and CarpX to its wholly owned incubator, PMX.
Starting with PortIO, the Company will seek to independently
finance a separate subsidiary of the incubator to develop and
commercialize each technology. Hatch Medical will provide strategic
advisory and brokerage services to the subsidiary to advance the
technology through key milestones and, subsequently, seek to engage
a strategic partner to acquire, license or distribute the
commercial product.
"We have been impressed with the commercial potential of these
technologies and the meticulous, high-caliber work that the PAVmed
team and its partners have put into their development to date,"
said Paul Gianneschi, Managing
Principal of Hatch Medical. "We are excited to leverage our product
leadership, industry expertise and other resources to help PAVmed
bring these novel technologies to market, as we have successfully
done for decades with other entrepreneurs and early-stage
companies."
Although the incubator, PMX, may seek to expand its portfolio
with internal or externally sourced technologies in the future, its
initial assets, as noted, will include:
- PortIO Implantable Intraosseous Vascular Access Device.
PortIO consists of an implantable intraosseous vascular access
device and insertion kit. Instead of a catheter located in a vein,
it has a short extension from the device, which a physician inserts
into a bone, leaving the device to reside completely beneath the
skin. This allows direct access to the bone marrow, which is a
well-established route for the delivery of medications, fluids, and
other substances. PortIO can be inserted and removed
near-percutaneously without requiring a surgical pocket or
significant dissection and does not require radiologic confirmation
of proper deployment. PAVmed completed IRB-approved First-in-Human
studies of PortIO in Colombia in
2022, with excellent device function and no complications across
nine patients. Extensive engagement with the FDA has established a
clear path to a U.S. Investigational Device Exemption (IDE)
clinical study and regulatory clearance through its de novo
pathway.
- EsoCure Esophageal Ablation Device. EsoCure is an
ablation system designed to treat late esophageal precancer
(dysplastic Barrett's Esophagus) which consists of single-use,
disposable balloon catheters that are delivered through the working
channel of a standard endoscope and a low-cost console to control
the ablation process. Incorporated within the EsoCure system is the
proprietary Caldus™ technology, a catheter design which allows for
controlled direct thermal tissue ablation without the need for an
intermediate energy source, such as radiofrequency. Prior to its
development pause, extensive development work, including numerous
animal studies, demonstrated that EsoCure created ablation lesions
similar or superior to those of the main commercially available
radiofrequency esophageal ablation device.
- CarpX® Minimally Invasive Device for Carpal
Tunnel Syndrome. CarpX is a patented single-use disposable
minimally invasive device designed to treat carpal tunnel syndrome
while reducing recovery times, which has received U.S. Food and
Drug Administration (FDA) 510(k) clearance and CE Mark. CarpX is
designed to closely mimic the anatomic results of invasive carpal
tunnel surgery, but much less invasively, using catheters,
balloons, radiofrequency energy and other established tools that
have contributed to percutaneous and minimally invasive revolutions
in the treatment of other conditions. The first-generation device
underwent a limited commercial release utilizing early adopter key
opinion leaders to advance procedural and product improvements.
Prior to its development pause, the Company was working on the
second generation CarpX device that would incorporate imaging and a
proprietary console.
About PAVmed
PAVmed Inc. is a diversified commercial-stage medical technology
company operating in the medical device, diagnostics, and digital
health sectors. Its majority-owned subsidiary, Lucid Diagnostics,
is a commercial-stage cancer prevention medical diagnostics company
that markets the EsoGuard® Esophageal DNA Test and EsoCheck®
Esophageal Cell Collection Device—the first and only commercial
tools for widespread early detection of esophageal precancer to
mitigate the risks of esophageal cancer deaths. Its other
majority-owned subsidiary, Veris Health Inc., is a digital health
company whose lead product is a digital cancer care platform with
physiologic data collection, symptom reporting and telehealth
functions, designed to improve personalized cancer care through
remote patient monitoring. Veris has also been developing an
implantable physiological monitor, designed to be implanted
alongside a chemotherapy port, which will interface with the Veris
cancer care platform.
For more and for more information about PAVmed, please visit
pavmed.com.
For more information about Lucid Diagnostics, please visit
luciddx.com.
For more information about Veris Health, please visit
verishealth.com.
Forward-Looking Statements
This press release includes forward-looking statements that
involve risk and uncertainties. Forward-looking statements are any
statements that are not historical facts. Such forward-looking
statements, which are based upon the current beliefs and
expectations of PAVmed's management, are subject to risks and
uncertainties, which could cause actual results to differ from the
forward-looking statements. Risks and uncertainties that may cause
such differences include, among other things, volatility in the
price of PAVmed's common stock; general economic and market
conditions; the uncertainties inherent in research and development,
including the cost and time required to advance PAVmed's products
to regulatory submission; whether regulatory authorities will be
satisfied with the design of and results from PAVmed's clinical and
preclinical studies; whether and when PAVmed's products are cleared
by regulatory authorities; market acceptance of PAVmed's products
once cleared and commercialized; PAVmed's ability to raise
additional funding as needed; and other competitive developments.
In addition, PAVmed continues to monitor the COVID-19 pandemic and
the pandemic's impact on PAVmed's businesses. These factors are
difficult or impossible to predict accurately and many of them are
beyond PAVmed's control. In addition, new risks and uncertainties
may arise from time to time and are difficult to predict. For a
further list and description of these and other important risks and
uncertainties that may affect PAVmed's future operations, see Part
I, Item 1A, "Risk Factors," in PAVmed's most recent Annual Report
on Form 10-K filed with the Securities and Exchange Commission, as
the same may be updated in Part II, Item 1A, "Risk Factors" in any
Quarterly Report on Form 10-Q filed by PAVmed after its most recent
Annual Report. PAVmed disclaims any intention or obligation
to publicly update or revise any forward-looking statement to
reflect any change in its expectations or in events, conditions, or
circumstances on which those expectations may be based, or that may
affect the likelihood that actual results will differ from those
contained in the forward-looking statements.
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SOURCE PAVmed Inc.