Vapotherm Announces FDA 510(k) Clearance for HVT 2.0 Next Generation Platform

Rhea-AI Summary

Vapotherm (NYSE: VAPO) announced the 510(k) clearance from the US FDA for its HVT 2.0 system, designed for high-velocity therapy without requiring wall air. This innovation addresses a significant limitation, as an estimated 50% of U.S. hospital beds lack wall air. The company plans a limited commercial release in Q4 2021, which aims to enhance patient care by alleviating ICU bed shortages and reducing emergency room congestion. The HVT 2.0 is also integrated with the Vapotherm Access digital platform for home patient monitoring.

Positive

• Received 510(k) clearance from the US FDA for HVT 2.0, enhancing market position.
• Addresses critical hospital needs with an estimated 50% of U.S. hospital beds lacking wall air.
• Planned limited commercial release in Q4 2021 could lead to increased revenue.

Negative

• Vapotherm has incurred past losses and may face challenges in achieving profitability.
• Dependence on the sales of Precision Flow systems puts revenue at risk.

EXETER, N.H.--(BUSINESS WIRE)-- Vapotherm, Inc. (NYSE: VAPO), (“Vapotherm” or the “Company”), today announced it has received 510(k) clearance from the US Food and Drug Administration for HVT 2.0. This next generation system is designed to provide high velocity therapy using an integrated air source, eliminating the need for wall air or any pressurized air source. It is estimated that 50% of U.S. hospital beds don’t have wall air. When paired with an oxygen source, the HVT 2.0 will support patients whether they need respiratory support in the hospital or home setting. The Company is planning a limited commercial release of HVT 2.0 in the United States in the fourth quarter of 2021.

“Clearance of HVT 2.0 enables us to provide high velocity therapy to Patients throughout the hospital, which is very important when ICU beds become scarce. It will allow hospitals to leverage their general care floors and potentially reduce emergency room crowding and wait times. We will also use this next generation platform, combined with the Vapotherm Access digital remote Patient monitoring platform, to begin learning how to treat complex lung disease Patients in the home,” said Joe Army, President and CEO of Vapotherm.

About Vapotherm

Vapotherm, Inc. (NYSE: VAPO) is a publicly traded developer and manufacturer of advanced respiratory technology based in Exeter, New Hampshire, USA. The company develops innovative, comfortable, non-invasive technologies for respiratory support of patients with chronic or acute breathing disorders. Vapotherm is focused on the development and commercialization of its proprietary Vapotherm high velocity therapy^® products which are used to treat patients of all ages suffering from respiratory distress. Over 3.0 million patients have been treated with the use of Vapotherm high velocity therapy systems. For more information, visit www.vapotherm.com.

Vapotherm high velocity therapy is mask-free noninvasive ventilatory support and is a front-line tool for relieving respiratory distress—including hypercapnia, hypoxemia, and dyspnea. It allows for the fast, safe treatment of undifferentiated respiratory distress with one tool. The Precision Flow system’s mask-free interface delivers optimally conditioned breathing gases, making it comfortable for patients and reducing the risks and care complexities associated with mask therapies. While being treated, patients can talk, eat, drink and take oral medication.

Website Information

Vapotherm routinely posts important information for investors on the Investor Relations section of its website, http://investors.vapotherm.com/. Vapotherm intends to use this website as a means of disclosing material, non-public information and for complying with Vapotherm’s disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of Vapotherm’s website, in addition to following Vapotherm’s press releases, Securities and Exchange Commission (“SEC”) filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Vapotherm’s website is not incorporated by reference into, and is not a part of, this document.

Legal Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements about the HVT 2.0 device, including statements about its functionality, market acceptance, market penetration, clinical efficacy in new settings of care including in the home and within hospitals, and the ability of the HVT 2.0 device to manage complex lung disease in combination with the Vapotherm Access remote patient monitoring platform. In some cases, you can identify forward-looking statements by terms such as ‘‘expect,’’ “continue” “will” or “typically,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words, or the use of future dates. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include, but are not limited to the following: Vapotherm has incurred losses in the past and may be unable to achieve or sustain profitability in the future, Vapotherm may need to raise additional capital to fund its existing commercial operations, develop and commercialize new products, and expand its operations, Vapotherm’s dependence on sales generated from its Precision Flow systems, competition from multi-national corporations who have significantly greater resources than Vapotherm and are more established in the respiratory market, the ability for HVT 2.0 systems to gain market acceptance and penetration, Vapotherm’s inexperience directly marketing and selling the HVT 2.0 device, lack of clinical experience using the HVT 2.0 device on patients and/or in new settings of care, the inability to effectively use the HVT 2.0 device in conjunction with the Vapotherm Access remote patient monitoring platform, the potential loss of one or more suppliers, Vapotherm’s susceptibility to seasonal fluctuations, Vapotherm’s failure to comply with applicable United States and foreign regulatory requirements, the failure to obtain U.S. Food and Drug Administration or other regulatory authorization to market and sell future products or its inability to secure, maintain or enforce patent or other intellectual property protection for its products, the impact of the COVID-19 pandemic on its business, including its supply chain, and the other risks and uncertainties included under the heading “Risk Factors” in Vapotherm’s Annual Report on Form 10-K for the fiscal year ended December, 31, 2020, as filed with the Securities and Exchange Commission on February 24, 2021, Vapotherm’s Quarterly Report on Form 10-Q for the quarters ended March 31, 2021 and June 30, 2021, as filed with the Securities and Exchange Commission on May 5, 2021 and August 9, 2021 respectively, and in any subsequent filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Vapotherm’s views as of the date hereof, and Vapotherm does not assume and specifically disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210830005160/en/

Investor Relations:

Mark Klausner or Mike Vallie, Westwicke, an ICR Company, ir@vtherm.com, +1 (603) 658-0011

Source: Vapotherm, Inc.

FAQ

What is HVT 2.0 and its significance for Vapotherm (VAPO)?

HVT 2.0 is a next-generation respiratory therapy system that received FDA clearance, providing high-velocity therapy without the need for wall air, significantly enhancing patient care.

When will Vapotherm (VAPO) launch HVT 2.0 in the market?

Vapotherm plans a limited commercial release of HVT 2.0 in the United States in Q4 2021.

How does HVT 2.0 improve patient care according to Vapotherm (VAPO)?

HVT 2.0 supports patients needing respiratory support, particularly in situations where ICU beds are scarce, and helps reduce emergency room congestion.

What are the financial risks for Vapotherm (VAPO) mentioned in the press release?

Vapotherm has experienced past losses and may struggle to achieve profitability, with reliance on Precision Flow system sales creating potential revenue risks.