Tag: healthcare

AI in Healthcare: The Next Frontier for Investors?

Posted on by slightbourne@noblecapitalmarkets.com

In the ever-evolving world of technology, few terms have captured the imagination of investors quite like artificial intelligence (AI). From autonomous vehicles to virtual assistants, AI has permeated nearly every facet of modern life, disrupting traditional business models and creating new opportunities for growth and innovation.

One sector that is increasingly feeling the transformative impact of AI is healthcare. As the industry grapples with challenges such as rising costs, workforce shortages, and the need for more personalized and efficient care, AI is emerging as a powerful tool to address these issues and unlock new frontiers in medicine.

The applications of AI in healthcare are vast and varied, ranging from drug discovery and disease diagnosis to patient monitoring and virtual nursing assistants. At the forefront of this revolution are companies that are harnessing the power of AI to develop cutting-edge solutions and drive technological advancements in the field.

One area where AI is making significant strides is medical imaging and diagnostics. Companies like Enlitic, a pioneer in deep learning for radiology, are developing AI systems that can analyze medical images with unprecedented accuracy, aiding in the early detection of diseases and reducing the risk of misdiagnosis. By automating and enhancing the analysis of X-rays, CT scans, and MRI images, these AI solutions have the potential to improve patient outcomes while reducing the workload on healthcare professionals.

Another promising application of AI in healthcare is drug discovery and development. Traditionally, the process of bringing a new drug to market has been time-consuming and costly, often taking years and billions of dollars in research and clinical trials. However, AI is revolutionizing this process by analyzing vast amounts of data, identifying promising drug candidates, and accelerating the drug discovery pipeline.

Companies are leveraging machine learning algorithms to search through millions of potential drug compounds, predicting their efficacy and safety profiles with remarkable accuracy. This not only speeds up the drug development process but also increases the likelihood of successful clinical trials and faster time-to-market for new therapies.

Beyond drug discovery and medical imaging, AI is also playing a crucial role in personalized medicine and patient care. Companies are developing AI-powered virtual healthcare assistants that can provide personalized medical advice, triage patients, and even monitor chronic conditions remotely. By leveraging natural language processing and machine learning, these AI solutions can offer accessible and affordable healthcare services, particularly in underserved or remote areas.

For investors, the proliferation of AI in healthcare presents both opportunities and challenges. On the one hand, the potential for groundbreaking innovations and disruptive technologies in this sector could translate into significant returns for those who identify and invest in the right companies early on. However, the healthcare industry is also heavily regulated, and navigating the complex web of regulatory approvals and clinical trials can be a significant hurdle for AI-driven healthcare solutions.

Furthermore, as with any emerging technology, there are ethical considerations and potential risks associated with the use of AI in healthcare. Concerns around data privacy, algorithmic bias, and the potential for AI to perpetuate or exacerbate existing healthcare disparities must be carefully addressed to ensure the responsible and equitable deployment of these technologies.

Despite these challenges, the investment community is eagerly watching the AI healthcare space, recognizing the immense potential for transformative innovations and lucrative returns. As the adoption of AI in healthcare continues to accelerate, companies that can successfully navigate the regulatory landscape, mitigate risks, and deliver tangible solutions that improve patient outcomes and healthcare efficiency are likely to emerge as leaders in this burgeoning field.

For savvy investors, the key to capitalizing on the AI healthcare revolution lies in conducting thorough due diligence, understanding the competitive landscape, and identifying companies with robust AI capabilities, strong intellectual property portfolios, and a clear path to commercialization and scalability.

While AI may be a buzzword that often moves markets, in the healthcare sector, it represents a genuine paradigm shift with the potential to save lives, reduce costs, and transform the way we approach healthcare delivery. As such, investors who can separate the hype from the reality and identify the true pioneers in this space may be well-positioned to reap the rewards of this technological revolution.

noble capital markets emerging growth virtual healthcare equity conference

Healthy Returns Ahead: Investor Outlook for the Telemedicine Sector

Posted on by slightbourne@noblecapitalmarkets.com

The COVID-19 pandemic accelerated a trend that was already underway – the transition to virtual healthcare. Telehealth and telemedicine platforms that enable patient-doctor video visits surged in popularity with the rise of social distancing. This shift towards healthcare digitization appears poised to continue shaping the industry landscape long after the pandemic subsides.

Companies at the forefront of virtual care technology saw demand for their platforms skyrocket since early 2020. Now, with telehealth becoming entrenched in patient and provider norms, these virtual health firms are emerging as stocks to watch. Their continued growth could transform how healthcare is accessed and delivered.

Surging into the Mainstream

The coronavirus outbreak necessitated remote interactions, making virtual doctor appointments a necessity. Healthcare providers rapidly ramped up telehealth offerings to comply with public health mandates while ensuring patient access.

According to McKinsey, telehealth utilization soared from 11% of US consumers in 2019 to 46% in 2020. Virtual healthcare visits increased 38-fold from the pre-pandemic baseline.

This abrupt shift illuminated the viability of remote care. Patients and providers alike found telehealth appointments efficient and convenient compared to in-office visits. Virtual options grant easy access for patients while maximizing provider capacity.

Significant majorities of patients now prefer a telehealth option according to surveys. With Covid risks waning, medical practices face patient demand to maintain virtual visit capabilities. This bodes well for companies specializing in telemedicine software and infrastructure.

“Virtual care proved its worth during an extremely trying time for the healthcare system,” said Alan Warren, MD and Chief Medical Officer of Epic Health Services. “Now patients know its value. Providers have invested in it. There’s no going back.”

New Market Leader?

Hims & Hers Health (NYSE: HIMS) operates a telehealth platform focused on serving millennial and gen-Z demographics. Its model emphasizes accessible virtual care for conditions like skin, sexual health, mental health, and primary care.

Since pandemic onset, Hims & Hers has seen tremendous growth as young consumers flocked to its digital offerings. Quarterly revenues grew 74% year-over-year in Q3 2023. The company now boasts over a million subscribers and expanded its medical provider network 10-fold.

Hims & Hers shares surged over 15% this past week on the back of strong Q3 results that beat analyst estimates. The company increased its FY 2023 revenue guidance by $5 million.

As adoption of virtual care increases, platforms like Hims & Hers that cater to digital-native populations could see outsized gains. Younger demographics are leading the charge in embracing telehealth’s convenience and privacy.

“Hims & Hers is emerging as uniquely positioned to capture the virtual care market for younger users who prefer seeking healthcare from their smartphones,” said Morgan Stanley analyst Daniella Perry. She projects the company will top $500 million in sales by 2025.

The New Normal

While uncertainty always exists around new technologies, virtual healthcare appears poised for growing prominence even post-pandemic. Patients favor the enhanced access, efficiency, and safety it affords. Providers can boost capacity and revenue with integrated telemedicine capabilities.

Regulatory changes also signal momentum. Recently proposed congressional legislation aims to permanently remove geographic restrictions on telehealth while increasing reimbursements to incentivize adoption. If passed, such measures would further propel widespread virtual care.

Meanwhile, more providers are investing in platforms to offer hybrid models blending physical and digital visits. Partnerships between health systems and technology vendors are becoming commonplace.

“Virtual healthcare is becoming standard,” said John Smith, Chief Medical Officer at MedCity Health. “We’ve implemented secure video visit capabilities across all our primary care clinics. Patients love the flexibility of on-demand telehealth for many common conditions and follow-ups.”

For innovative companies enabling this care transformation, analysts see blue sky ahead. As telehealth becomes entrenched in care delivery norms, firms providing user-friendly, scalable platforms could capture enormous value. The next time you need to see a doctor, the visit may very likely take place online.

Veradigm Bets on AI, Acquires ScienceIO for $140M

Posted on by slightbourne@noblecapitalmarkets.com

Healthcare technology firm Veradigm announced a deal this week to purchase artificial intelligence (AI) startup ScienceIO for $140 million in cash. The acquisition provides Veradigm with advanced AI capabilities to derive insights from its health data assets.

Chicago-based Veradigm offers data platforms and software solutions for healthcare stakeholders including providers, insurers, and pharmaceutical companies. The company claims its network covers over 400,000 healthcare providers and 200 million patients.

ScienceIO, founded in 2019, has developed AI models and platforms specifically for healthcare applications. Its natural language processing models can extract information from complex medical text and records.

Powered by this AI, Veradigm aims to launch next-generation analytics products that enhance clinical decision-making and improve patient outcomes across its customer base.

Accelerating Growth Through AI

The merger agreement comes as Veradigm looks to reposition itself as a high-growth data analytics leader. Management believes integrating ScienceIO’s technology is key to that transformation.

In the press release, Veradigm Interim CEO Yin Ho said the acquisition “will be able to provide more highly differentiated and advanced products to provider, payer and life sciences customers.”

The company’s Executive Chairman Greg Garrison also called the deal “a natural next step in the strategy…to drive continued growth across our business units.”

Veradigm plans to leverage ScienceIO’s platform to build custom natural language processing models trained on its own proprietary health data. Running advanced analytics on its comprehensive provider and patient dataset will uncover previously untapped insights.

The focus will be developing AI-enabled offerings while ensuring full compliance with healthcare data privacy regulations. This will likely necessitate keeping modeling and computation on Veradigm’s controlled systems rather than via public cloud services.

Presenting Company Registration Now Open! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More

Near-Term Growth and Long-Term Potential

Incorporating ScienceIO’s technology throughout its product portfolio will help accelerate new feature development, per Veradigm management. Enhanced offerings could then drive near-term revenue growth.

But the larger potential impact is establishing Veradigm as a leader in next-generation intelligent healthcare systems. AI-powered analytics promise to transform areas like clinical diagnostics, patient risk assessment, and treatment decision support.

Veradigm highlighted that its unique combination of data breadth and advanced analytics can lead to “higher quality, lower cost care for patients.” This goal aligns with the current shift towards value-based care in the healthcare sector.

The transaction is expected to close within weeks, subject to customary closing conditions. ScienceIO’s team will likely join Veradigm’s existing technology group.

Plans for integrating operations and migrating customers to enhanced AI offerings will be critical during the post-merger integration process. Realizing the promised growth synergies rapidly will demonstrate the strategic logic of the deal.

What Competition and Customers Can Expect

For competitors, Veradigm gaining potent AI abilities raises the stakes in the race to provide smarter healthcare analytics tools. AI-driven insight platforms are seen as a major battleground in the industry.

The deal pressures other players to advance their own AI or seek technology acquisitions to keep pace. Industry titans like Optum and IQVIA have already been aggressive on the M&A front, snapping up emerging analytics firms.

Ultimately, it’s healthcare payers and providers that need to see material improvements from AI adoption. They will expect Veradigm’s new data products to deliver actionable insights that improve patient outcomes and the bottom line.

If Veradigm can successfully integrate ScienceIO’s capabilities across its client verticals, it will cement its positioning as a partner that can drive impact from healthcare data analytics.

But the company must also tread carefully, as the sensitive nature of health data makes privacy preservation paramount. Responsible data usage and ethics around AI will determine customer and public perception.

AstraZeneca Shares Drop Despite Strong 2024 Outlook

Posted on by slightbourne@noblecapitalmarkets.com

Shares of pharmaceutical giant AstraZeneca fell over 6% despite the company projecting double-digit growth for 2024. Investors were disappointed by AstraZeneca missing Q4 earnings expectations due to rising costs. However, smaller healthcare firms may offer more upside potential.

AstraZeneca reported fourth quarter core earnings per share of $1.45, below analyst estimates of $1.50. Higher research and development costs weighed on profits. Meanwhile, total revenue edged above expectations at $12.02 billion.

The company expects low double-digit percentage increases in both total revenue and core earnings per share in 2024. This robust guidance is driven by AstraZeneca’s oncology and rare disease drugs.

However, shares dropped as investors focused on the earnings miss and product mix in the latest quarterly results. While AstraZeneca maintains a strong long-term outlook, its scale and mature product portfolio limit rapid growth.

This has led some investors to turn their attention to younger healthcare companies in search of higher growth potential. Smaller biotechs and emerging medtech firms can offer more upside, albeit with higher risk.

For example, cancer immunotherapy developer Silverback Therapeutics went public in late 2020 and has seen its stock price triple over the last year. The company is advancing treatments that harness the body’s immune system to fight cancer.

Other high-growth areas include digital health, where newly public firms like GoodRx are disrupting pharmacy and drug pricing. And healthcare tech provider Oak Street Health has surged over 200% since its 2020 IPO.

These younger healthcare firms tend to have higher volatility compared to big pharmas like AstraZeneca. But their focus on new innovations and faster growth in underpenetrated markets make them appealing for growth-oriented investors.

However, due diligence is required as many of these stocks go on to underperform or even fail. Factors like clinical trial results, regulatory approvals, and market adoption can make or break emerging health stocks.

Diversification across multiple companies can help mitigate the risk. Investing in a healthcare-focused ETF is one method to gain diversified exposure to both mature drugmakers and higher-growth emerging stocks.

Additionally, many biotech and medtech IPOs have been impacted by the 2022/2023 bear market. This offers an opportunity for investors to buy promising stocks at lower valuations.

Overall, AstraZeneca maintains a healthy long-term outlook supported by its deep pipeline of new drugs. But near-term headwinds like rising costs and the latest earnings miss dragged shares lower.

This illustrates how even strong incumbent firms face challenges sustaining rapid growth. For investors seeking higher growth potential, carefully selected emerging healthcare stocks can provide more upside.

However, realizing this potential requires thorough due diligence. Not all emerging companies succeed, making diversification and patience key when investing in new healthcare names. But buying into the right stocks early can result in tremendous gains over the long-term.

The health sector’s constant innovation ensures exciting new companies will continue disrupting incumbents. While mature pharmas like AstraZeneca play a key role in the market, fast-growing upstarts are where outsized returns often lie.

Novo Holdings Announces Catalent Acquisition

Posted on by cpatches

In a strategic move aimed at addressing the soaring demand for its revolutionary weight-loss drug, Wegovy, Novo Holdings, the parent company of Novo Nordisk, has disclosed plans to acquire contract drug maker Catalent for $11.5 billion in cash. This acquisition is poised to fortify Novo Nordisk’s production capabilities in response to the extraordinary demand for innovative weight loss and diabetes medications.

Novo Holdings will acquire Catalent for $11.5 billion in cash. As part of the deal, Novo Nordisk will purchase three Catalent fill-finish sites, bolstering the production of Wegovy and other crucial medications. The acquisition is strategically driven by the exceptional demand for Wegovy and Ozempic over the past year.

Novo anticipates that the deal will have a low single-digit percentage negative impact on operating profit growth in 2024 and 2025. The terms include the acquisition of all outstanding shares of Catalent for $63.50 per share in cash, representing a premium of 16.5% to the company’s last trading price. Novo will also assume Catalent’s debt, bringing the total enterprise value of the deal to $16.5 billion.

The acquisition is expected to gradually increase Novo’s filling capacity, with notable effects expected from 2026 onwards. The three fill-finish sites, located in Italy, Belgium, and Bloomington, Indiana, will play a crucial role in supporting Novo Nordisk’s expanding drug portfolio.

In the growing obesity drug market, Novo Nordisk faces competition from Eli Lilly’s Zepbound. Analysts estimate that the obesity drug market could reach $100 billion by the end of the decade, highlighting the immense potential for companies in this sector.

The acquisition aligns seamlessly with Novo Holdings’ strategy of investing in established life science companies with significant long-term potential. Catalent’s expertise in enabling pharmaceutical, biotech, and consumer health partners is in harmony with Novo Holdings’ commitment to improving health and sustainability.

The merger is anticipated to close by the end of calendar year 2024, subject to customary closing conditions, Catalent stockholder approval, and regulatory approvals. Catalent’s Board unanimously recommends that stockholders vote in favor of the merger, following an evaluation of value-maximizing alternatives.

Kasim Kutay, CEO of Novo Holdings, expressed excitement about the partnership with Catalent and emphasized their commitment to supporting Catalent’s growth and mission to develop products that enhance lives.

Novo Holdings’ acquisition of Catalent represents a strategic move to strengthen production capabilities and meet the escalating demand for transformative medications like Wegovy. As the merger progresses, it not only positions Novo Nordisk for continued success in the competitive pharmaceutical landscape but also aligns with Novo Holdings’ broader mission of investing in high-quality life sciences companies for the betterment of society and the planet. The industry will be closely watching the outcome of this significant acquisition, anticipating positive impacts on Novo Nordisk’s product development and market position.

Mark your calendars! Don’t miss Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on April 17-18. This exclusive virtual event connects investors with 50 leading public biotech, healthcare services, and medical device companies. Presenting company slots are available…Read More

Cigna Unloads Medicare Assets for $3.7B, Ups Investments in Core Segments

Posted on by slightbourne@noblecapitalmarkets.com

Health insurer Cigna announced Wednesday it is divesting its Medicare Advantage, Medicare Part D, and other Medicare operations to Health Care Service Corporation (HCSC) in a $3.7 billion cash deal.

Cigna said the sale will streamline its business to focus on growing its health services and benefits platforms. Proceeds will also fund share repurchases, with the transaction expected to be accretive to adjusted earnings per share in 2025.

Refocusing the Portfolio

The sale includes Cigna’s Medicare Advantage plans, Medicare Part D prescription drug plans, Cigna Supplemental Benefits, and the CareAllies health support services unit.

With HCSC taking over these businesses, Cigna can direct more investment and resources toward expanding its Evernorth health services division and Cigna Healthcare commercial health benefits segment.

Evernorth provides pharmacy benefits management, specialty pharmacy, and health technology solutions. Cigna Healthcare offers employer-sponsored group health plans as well as individual plans.

While Cigna sees Medicare as an attractive market, the segment required outsized focus and capital relative to its size within Cigna’s broader portfolio. The sale unlocks value and simplifies operations.

Gaining Scale and Capabilities

For HCSC, the transaction accelerates growth in Medicare, where the company has over 1 million members currently across 7 states. Adding Cigna’s Medicare customers and capabilities will expand HCSC’s geographic reach and enhance its product portfolio.

The businesses being acquired generated around $5.5 billion in 2022 revenues for Cigna. So the deal provides HCSC with meaningful membership and revenue growth in Medicare and immediate scale.

Cigna built a significant presence in Medicare through organic growth and acquisitions like HealthSpring in 2011. HCSC gains these customer relationships and infrastructure with the purchase.

Focusing on What Cigna Does Best

Cigna has been optimizing its portfolio under CEO David Cordani to concentrate on its core competencies. Last year, Cigna sold its international life, accident, and supplemental benefits businesses.

The Medicare sale continues this strategic focus on areas where Cigna has differentiated capabilities and growth opportunities. Evernorth provides unique pharmacy solutions and analytics. Cigna Healthcare leverages the company’s strong employer and health plan expertise.

The transaction value of $3.7 billion represents about 10 times Medicare Advantage customer revenue and 16 times Medicare Part D customer revenue. This appears a solid price for Cigna to unlock capital from non-core assets.

Financial Benefits

Cigna expects the deal will be 5-10% accretive to adjusted EPS in 2025 once completed. The company reaffirmed its 2024 outlook and long-term 10-13% annual EPS growth target.

Proceeds from the divestiture will primarily fund share buybacks, representing an attractive return of capital for investors. Cigna previously had around $7.5 billion remaining on its buyback authorization.

The deal is expected to close in the first quarter of 2025 after securing necessary regulatory clearances. There is no financing condition, providing transaction certainty.

Overall, the sale highlights Cigna’s disciplined portfolio approach to drive shareholder value. Consolidating its focus while monetizing Medicare strengthens Cigna’s growth trajectory in targeted segments. For HCSC, the deal accelerates its diversification into a key government market.

Release – DLH to Announce Fiscal 2024 First Quarter Financial Results

Posted on by aweinsoff@channelchek.com

Research News and Market Data on DLH

January 22, 2024

ATLANTA, Jan. 22, 2024 (GLOBE NEWSWIRE) — DLH Holdings Corp. (NASDAQ: DLHC) (“DLH” or the “Company”), a leading healthcare and human services provider to the federal government, will release financial results for the fiscal first quarter ended December 31, 2023 on January 31, 2024 after the market closes. DLH will then host a conference call for the investment community at 10:00 a.m. Eastern Time the following day, February 1, 2024, during which members of senior management will make a brief presentation focused on the financial results and operating trends. A question-and-answer session will follow. 

Interested parties may listen to the conference call by dialing 888-347-5290 or 412-317-5256.  Presentation materials will also be posted on the Investor Relations section of the DLH website prior to the commencement of the conference call. A digital recording of the conference call will be available for replay two hours after the completion of the call and can be accessed on the DLH Investor Relations website or by dialing 877-344-7529 and entering the conference ID 1843140.
  
About DLH
DLH (NASDAQ: DLHC) enhances technology, public health, and cyber security readiness missions through science, technology, cyber, and engineering solutions and services. Our experts solve some of the most complex and critical missions faced by federal customers, leveraging digital transformation, artificial intelligence, advanced analytics, cloud-based applications, telehealth systems, and more. With over 3,200 employees dedicated to the idea that “Your Mission is Our Passion,” DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to innovative solutions to improve the lives of millions. For more information, visit www.DLHcorp.com.

INVESTOR RELATIONS
Contact: Chris Witty
Phone: 646-438-9385
Email: cwitty@darrowir.com

AMN Healthcare Expands Its Footprint with Acquisition of MSDR

Posted on by cpatches

AMN Healthcare (NYSE: AMN), a prominent player in total talent solutions for healthcare organizations across the United States, has announced its plans to acquire MSDR, marking a significant move in the healthcare staffing sector. The definitive agreement, with a purchase price of $300 million, encompasses two healthcare staffing companies, Medical Search International (MSI) and DRW Healthcare Staffing (DRW), both of which specialize in locum tenens and advanced practices.

Meet the Companies:

MSI, established in 2002, is renowned for its services in placing high-quality healthcare professionals specializing in psychiatry, anesthesia, radiology, and surgery, serving healthcare systems throughout the United States. DRW, founded in 2011, boasts expertise in psychiatry, anesthesia, and surgery placements, making it a valued leader in the locum tenens industry. Notably, Chris Wang, the Chief Executive Officer and Managing Partner of DRW, will continue to contribute as the President of MSDR.

Growth Prospects and Financials:

This strategic acquisition positions AMN Healthcare for substantial revenue growth within the locum tenens sector. In 2022, MSDR generated $104 million in revenue, and the annualized revenue for 2023 stands at approximately $155 million. AMN anticipates the deal to be modestly accretive to adjusted earnings per share (EPS) within the first 12 months of integration.

The acquisition is slated to close in the fourth quarter of 2023, contingent on regulatory approvals and closing conditions. It will be treated as an asset purchase, creating a step-up in the tax basis for the intangible assets acquired.

Expanding Solutions and Expertise:

With the integration of MSDR, AMN Healthcare’s extensive portfolio of solutions is set to expand significantly. Clients will gain access to a larger and more diverse candidate pool, including healthcare professionals specializing in some of the most sought-after and in-demand services.

Moreover, the acquisition brings the wealth of expertise and knowledge of the MSDR team in recruitment, placement, and operations, coupled with candidate matching technology tailored for locum tenens. This move underscores AMN Healthcare’s commitment to delivering high-quality, tailored workforce solutions.

Commentary from Leadership:

AMN Healthcare President and Chief Executive Officer Cary Grace expressed enthusiasm about the acquisition, stating, “We are very excited to welcome the MSDR team into the AMN Healthcare family and expand the workforce solutions available to our clients across the country.” The move signifies a strategic growth opportunity that positions AMN Healthcare as a stronger and more comprehensive player in the healthcare staffing industry, ultimately benefitting both healthcare organizations and the dedicated professionals they serve.

Explore more healthcare and biotechnology stocks covered by Noble Senior Analysts Gregory Aurand and Robert LeBoyer

FDA Program May Help Investors Uncover Breakthrough Medical Technology

Posted on by cpatches

The FDA Breakthrough Devices Program may be a starting point for investors exploring the medical space. It’s designed to create a quicker path for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversible conditions. There are significant benefits for the companies granted access to the program. Lists of devices after the companies have been granted a marketing authorization are available on the FDA website.

While new pharmaceuticals tend to grab headlines quicker than devices, investors looking for public companies, that may be uncorrelated to the pace of US economic growth or the financial markets, may visit the website and then research the companies on Channelchek.

Image Credit: US Food and Drug Administration (Flickr)

Benefits of the Breakthrough Devices Program

The purpose of the Breakthrough Devices Program is to provide patients and health care providers with timely access to novel medical devices by speeding up their development, assessment, and review. At the same time, it preserves the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

Manufacturers have the opportunity to interact with the FDA’s experts through several different program options to efficiently address issues that present themselves during the FDA premarket review phase. This feedback from the FDA helps shorten the agreement phase. The company can also expect a prioritized review of its submission. This can have the effect of speeding the product to market with less cost and fewer problems.

How this Works

Pulling an example from the Channelchek library of videos from NobleCon18, we can use Perimeter Medical Imaging AI (PYNKF) to understand what a candidate looks like and how it may bring value to the patient, medical provider, and possibly investors.

Perimeter is an early-stage medical device company that expects its flagship product to address unmet cancer treatment needs. Initially, the device is expected to change the way breast cancer is treated and evaluated to improve outcomes and minimize the chance of recurrence or having to reoperate. In order to apply for the FDA designation, Perimeter’s device was indicated for breast cancer. However, the applications are expected to extend well beyond and into other major cancers in the $3.7 billion total market.

This FDA designation makes for a much more clear regulatory pathway. Perimeter meets the first guideline in that its product has unique technology (breakthrough) that is solving problems with a different method on a scalable platform. The procedures are expected to reduce the cost to patients, minimize the need for repeat surgery and be self-funding from the hospitals’ standpoint. This is because about 20 to 25% of cancer patients now need to return for a re-operation that costs approximately $16,000. Hospitals that adopt the Perimeter AI technology could serve patients better and stand to recover their costs while reducing overall patient costs on average.

Take-Away

There are many ways to uncover companies that are “on the move.” Reviewing those the FDA is likely to help along toward a full “go-ahead” is just one of them. For a more detailed look at Perimeter, their unique business model,  and technology, watch the 20-minute video below. For more on understanding the FDA Breakthrough Device Program in order to uncover companies that could change medicine, go to FDA.gov .

To evaluate small and growing companies, explore Channelchek beginning here.

Paul Hoffman

Managing Editor, Channelchek