PAVmed Launches Incubator to Advance Existing Pipeline Technologies including PortIO, EsoCure and CarpX
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Insights
The joint venture between PAVmed's incubator PMX and Hatch Medical represents a strategic move to reinvigorate the development and commercialization of PAVmed's medical technology portfolio. The focus on the PortIO device, in particular, is noteworthy given its unique approach to vascular access, potentially offering advantages over traditional catheter-based systems. The First-in-Human studies in Colombia and ongoing FDA engagement indicate a commitment to rigorous clinical evaluation and a clear regulatory strategy.
From an industry perspective, the success of such innovative devices hinges on their ability to demonstrate clinical efficacy, cost-effectiveness and ease of use compared to existing standards of care. The medical device market is highly competitive, with stringent regulatory hurdles. However, the partnership with Hatch Medical, which brings experience in advancing medical technologies, could provide the necessary expertise to navigate these challenges and accelerate market entry.
For investors, the key considerations will be the scalability of the technology, the addressable market size and the potential for strategic partnerships or acquisitions. The de novo pathway for FDA clearance mentioned for PortIO suggests a novel and unclassified device, which could either present an opportunity for market leadership or additional regulatory challenges. The financial implications of this venture will depend on the successful clinical development and commercial uptake of these devices.
The strategic decision by PAVmed to partner with Hatch Medical is a calculated effort to leverage Hatch's brokerage and advisory expertise to navigate the commercial landscape. The medical device industry is characterized by rapid innovation and a complex regulatory environment. Companies like PAVmed often require specialized knowledge to effectively bring products to market, particularly when dealing with groundbreaking technologies like PortIO, EsoCure and CarpX.
For stakeholders, the joint venture could represent a diversification strategy aimed at mitigating risk and maximizing the potential of PAVmed's portfolio. By structuring the incubator to independently finance each subsidiary, PAVmed is potentially creating focused entities that can attract investment and partnerships specifically tailored to each technology. This approach could enhance the value proposition for potential strategic partners or acquirers, as each technology can be developed and positioned according to its unique market dynamics.
The healthcare industry is increasingly moving towards minimally invasive procedures and devices like CarpX align with this trend. The regulatory clearance already obtained for CarpX bodes well for its commercial prospects, provided the second-generation improvements align with market needs and physician preferences. The long-term impact on PAVmed's business will likely depend on the execution of the development strategy and the ability to secure strategic partnerships or acquisitions at optimal valuations.
The joint venture between PAVmed's PMX incubator and Hatch Medical is a strategic initiative with potential financial implications for PAVmed's stock. The allocation of resources towards the incubator and the focus on the PortIO, EsoCure and CarpX devices suggest an intent to prioritize R&D and commercialization efforts within PAVmed's portfolio. This could signal to investors a proactive approach to innovation and a desire to capture market share in the medical device sector.
Investors will be interested in the financial structure of the joint venture, particularly the terms under which Hatch Medical will provide advisory services and the expected capital requirements for the development of the technologies. The announcement indicates a plan to independently finance the subsidiaries for each technology, which may involve raising capital through equity or debt offerings, partnerships, or grant funding. The ability to secure financing at favorable terms will be critical to the viability of the initiative.
The potential for these devices to address unmet medical needs represents an opportunity for revenue growth. However, investors should be aware of the risks associated with the development of medical technologies, including regulatory challenges, market acceptance and competition. The successful commercialization of the technologies could enhance PAVmed's financial performance in the long term, but the path to profitability is likely to be a multi-year process with considerable investment required upfront.
The incubator, PMX, and medical device firm Hatch Medical, execute joint venture agreement to complete their development and commercialization, starting with PortIO
"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 aU.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.
FAQ
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Which medical technologies are included in the initial assets of the PMX incubator?
What is the unique feature of PortIO Implantable Intraosseous Vascular Access Device?
What is the regulatory status of CarpX Minimally Invasive Device for Carpal Tunnel Syndrome?
Who is the Managing Principal of Hatch Medical impressed with the commercial potential of the technologies?
