Hyperfine, Inc. Continues Global Market Expansion by Entering Into a Distribution Partnership with Radiosurgery Global, Ltd. to Bring the Swoop® System to India
Hyperfine (Nasdaq: HYPR) is expanding its global reach by partnering with Radiosurgery Global to distribute its portable MR imaging system, Swoop®, in India. This strategic move addresses India's significant shortage of MRI scanners, with fewer than 5,000 units for over 1.4 billion people. The Swoop® system is designed to enhance diagnostic capabilities, particularly in underserved critical care and emergency settings. Hyperfine also plans future expansions into Malaysia, Indonesia, and Singapore. The company’s expansion is bolstered by recent certifications in the EU and UK and aims for regulatory approval in India through CDSCO. This collaboration signifies a major step toward improving healthcare accessibility and patient outcomes across Asia.
- Partnership with Radiosurgery Global to distribute Swoop® in India, Malaysia, Indonesia, and Singapore.
- Targets a significant market gap in India with fewer than 5,000 MRI scanners for 1.4 billion people.
- Addresses critical care and emergency settings where only 15% of trauma centers have MRI capabilities.
- Received CE and UKCA certifications in 2023, indicating strong international compliance.
- Plans for regulatory approval with CDSCO in India, aiming for commercialization in 2025.
- Potential to enhance patient care in over 69,000 public and private hospitals across India.
- Swoop® system offers high image quality and usability, making it suitable for varied healthcare settings.
- Expanding into Europe with appointed distributors in France, UK, and Italy.
- Potential delays in regulatory approval through CDSCO may impact commercialization timelines.
- Expansion into new markets involves significant financial investment and risk.
- High dependence on partner Radiosurgery Global for successful market entry.
Insights
Hyperfine's entry into the Indian market through a distribution partnership with Radiosurgery Global, Ltd. presents a notable opportunity to tap into a vastly underserved MRI market. With fewer than 5,000 MRI scanners for over 1.4 billion people, the introduction of the Swoop® system fills a significant gap, especially in critical care and emergency settings where traditional MRI scanners are scarce. The portability of the Swoop® system means healthcare facilities, even in remote areas, can benefit from advanced diagnostic imaging, potentially transforming patient outcomes.
From a market expansion perspective, Asia, particularly India, represents a high-growth potential region due to its large population and growing healthcare needs. The demand for advanced medical technologies is rising due to the increasing prevalence of chronic diseases like stroke and brain tumors. By entering this market, Hyperfine is positioning itself to become a important player, potentially increasing its market share and revenue streams substantially.
Moreover, the regulatory approvals that Hyperfine has already secured in Europe and the UK bolster its credibility and pave the way for smoother entry into other international markets, including India. This global expansion strategy, if executed well, could significantly enhance Hyperfine's competitive edge and market footprint.
The Swoop® system's portability and advanced imaging capabilities address critical gaps in healthcare infrastructure, particularly in regions like India where traditional MRI access is limited. By bringing MRI technology to underserved areas, Hyperfine is not just expanding its market but also contributing to better healthcare delivery. The ability to provide quick, reliable brain imaging in emergency and critical care settings can significantly improve diagnosis and treatment outcomes for conditions such as stroke and brain tumors.
Additionally, the system's application in pediatric care, which often requires specialized imaging capabilities, adds another layer of value. The emphasis on bringing such technology to varied settings—from urban hospitals to rural clinics—means a broader range of patients can benefit, potentially reducing healthcare disparities.
From a financial perspective, Hyperfine's strategic partnership with Radiosurgery Global, Ltd. is poised to create significant long-term value. The expansion into a largely untapped market like India, along with future potential in Malaysia, Indonesia and Singapore, provides a new revenue stream that could positively impact the company's financial health. The global market expansion aligns with Hyperfine's growth strategy, showing a proactive approach to scaling its business.
Investors should note the potential for increased sales volume and market penetration. Given the current shortage of MRI scanners in India, the demand for the Swoop® system could be substantial, translating into robust sales growth. Furthermore, expanding the market presence could enhance Hyperfine's brand recognition and pave the way for future product launches.
However, the initial costs associated with market entry, regulatory approvals and distribution agreements should also be considered. While the long-term prospects are promising, there might be short-term financial pressures.
Strategic focus on
The clinical value of the Swoop® system is applicable globally as Hyperfine, Inc. aims to expand overall access and availability of MRI. In
“Expanding commercially to
“This partnership marks a significant crossroads for the entire region as we bring state-of-the-art portable MR brain imaging technology within reach of vast, underserved populations,” said Kapil Kalra, Managing Director of Radiosurgery Global, Ltd.
“The innovative Swoop® system aligns perfectly with our mission to democratize healthcare access in over 69,000 public and private hospitals across
The expansion into global markets is supported by the company’s strong track record of securing international approvals for the Swoop® system. In 2023, Hyperfine, Inc. obtained CE certification under the EU MDR and UKCA certification in the
The system the company is introducing to the European and Indian markets is commercialized in the
For more information about the Swoop® Portable MR Imaging® system, please visit hyperfine.io.
About the Swoop® Portable MR Imaging® System
The Swoop® Portable MR Imaging® system is
About Hyperfine, Inc.
Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit hyperfine.io.
The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the “Company”) may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s goals and commercial plans, the benefits of the Company’s products and services, and the Company’s future performance and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the impact of COVID-19 on the Company’s business; the inability to maintain the listing of the Company’s Class A common stock on the Nasdaq; the Company’s inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in Company’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240528157535/en/
Media Contact
Shay Smith
Health+Commerce
shay@healthandcommerce.com
Investor Contact
Marissa Bych
Gilmartin Group LLC
marissa@gilmartinir.com
Source: Hyperfine, Inc.
FAQ
What is the recent partnership Hyperfine (HYPR) announced?
How many MRI scanners are currently available in India?
What certifications has Hyperfine (HYPR) received for the Swoop® system?
What is the significance of the partnership between Hyperfine (HYPR) and Radiosurgery Global?
When does Hyperfine (HYPR) aim to commercialize the Swoop® system in India?
