Alpha Tau Receives Medical Device Single Audit Program (MDSAP) Certification

Rhea-AI Summary

Alpha Tau Medical (NASDAQ: DRTS) has achieved Medical Device Single Audit Program (MDSAP) certification for its Jerusalem manufacturing facility. This certification, established by regulatory authorities from Australia, Brazil, Canada, Japan, and the U.S., enables medical device manufacturers to undergo a single audit for ISO 13485 compliance and standards across these five markets.

The MDSAP certification may accelerate the commercialization timeline in participating countries through a streamlined auditing process. This achievement reflects Alpha Tau's commitment to quality, safety, and regulatory compliance while supporting the global expansion of their Alpha DaRT® alpha-radiation cancer therapy for solid tumors.

Positive

• Obtained MDSAP certification enabling access to 5 major markets
• Potential acceleration of commercialization timeline in participating countries
• Streamlined regulatory compliance process across multiple jurisdictions

Negative

• None.

Insights

Medical Device Regulatory Expert

The MDSAP certification represents a strategic regulatory breakthrough that significantly enhances Alpha Tau's commercialization prospects for their Alpha DaRT cancer therapy. This certification effectively creates a fast-track pathway to five major markets with a combined healthcare spending exceeding $5 trillion annually.

The certification's value extends beyond mere regulatory compliance. It validates Alpha Tau's manufacturing capabilities and quality management systems against stringent international standards, potentially reducing market entry timelines by 6-18 months in each territory. This accelerated timeline could translate into substantial cost savings in regulatory compliance and earlier revenue generation opportunities.

From a manufacturing perspective, the MDSAP certification positions Alpha Tau to:

• Scale production more efficiently across multiple markets without requiring separate facility audits
• Reduce quality compliance costs by consolidating multiple regulatory requirements into a single system
• Strengthen their competitive position against potential market entrants who would need to undergo separate certification processes

The timing of this certification is particularly strategic as it aligns with Alpha Tau's ongoing clinical trials and suggests readiness for commercial-scale manufacturing. This preparatory step typically indicates confidence in upcoming trial results and anticipated market approvals, representing a important de-risking event for their commercialization strategy.

JERUSALEM, Feb. 24, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT^®, today announced the achievement of Medical Device Single Audit Program (MDSAP) certification for the company’s manufacturing facility in Jerusalem, as part of the Company’s commitment to quality, safety, and regulatory compliance while accelerating the global expansion of alpha-radiation cancer therapy through the manufacturing of the Alpha DaRT.

MDSAP was established by a coalition of international medical device regulatory authorities from Australia, Brazil, Canada, Japan and the U.S., to enable medical device manufacturers to be audited once for compliance with ISO 13485 and the standards of these five different markets. MDSAP certification may also speed the timetable to commercialization within these participating geographies, as it allows for a streamlined auditing process, providing manufacturers with a comprehensive approach to meet international regulatory standards efficiently.

“This milestone underscores our ability to expand our manufacturing capabilities expediently and efficiently as we continue to pursue marketing approvals across multiple geographies,” said Uzi Sofer, CEO of Alpha Tau. “We are hopeful that this will also expedite our progress in bringing to market a game-changing product for the treatment of solid tumors.”

“This huge achievement was made possible by the diligent work of our teams across regulatory, QA, R&D, production and engineering, who remain ever committed to delivering high-end innovative quality products while continually increasing production capacity to meet the growing demand for our products in clinical trials,” said Yaniv Sagie, VP of Quality & Regulatory Affairs at Alpha Tau.

About Alpha Tau Medical Ltd.

Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.

About Alpha DaRT®

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

Forward-Looking Statements

This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical studies to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq's listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's annual report filed on form 20-F with the SEC on March 7, 2024, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau's views as of any date subsequent to the date of this press release.

Investor Relations Contact:
IR@alphatau.com

FAQ

What does the MDSAP certification mean for Alpha Tau Medical (DRTS)?

The MDSAP certification allows Alpha Tau to undergo a single audit for compliance across five major markets (Australia, Brazil, Canada, Japan, and U.S.), potentially accelerating commercialization timelines and streamlining regulatory processes.

Which countries are included in Alpha Tau's (DRTS) MDSAP certification?

The MDSAP certification covers five countries: Australia, Brazil, Canada, Japan, and the United States.

How will the MDSAP certification impact Alpha Tau's (DRTS) market expansion?

The certification may speed up the commercialization timeline in participating countries through a streamlined auditing process, supporting the global expansion of Alpha DaRT therapy.

What product is Alpha Tau (DRTS) manufacturing under the MDSAP certification?

Alpha Tau is manufacturing the Alpha DaRT®, an innovative alpha-radiation cancer therapy for the treatment of solid tumors.