BioSig Announces Cost Reductions to Improve its Financial Standing and Shifts its Core Strategy

Rhea-AI Summary

BioSig Technologies, Inc. (NASDAQ: BSGM) announced a workforce reduction to reduce annual cash burn by 50%. The company is shifting its business model to partner with organizations for sales distribution and clinical support of its PURE EP™ Platform. The platform's NFT algorithm has shown a 66% reduction in ablation time, and the company is looking to expand its applications and quantify the efficacy and safety benefits of NFT.

Positive

• Workforce reduction to reduce annual cash burn by 50%
• Shifting business model to partner with organizations for sales distribution and clinical support of PURE EP™ Platform
• NFT algorithm has shown a 66% reduction in ablation time
• Looking to expand applications and quantify the efficacy and safety benefits of NFT

Negative

• None.

Financial Analyst

The announcement by BioSig Technologies of a workforce reduction to halve its annual cash burn is a significant strategic move that suggests a pivot towards a leaner operational model. In the context of medical technology firms, cash burn is a critical metric as it indicates the rate at which a company spends its cash reserves before it becomes profitable or secures additional funding. A 50% reduction is substantial and signals to investors a potential improvement in the company's financial sustainability. However, investors should also consider the potential risks associated with reduced personnel, such as slowed innovation or operational delays, which could impact the company's long-term growth prospects.

Moreover, BioSig's shift in strategy towards business development and distribution partnerships could be a double-edged sword. While it may reduce overhead costs and accelerate market penetration for the PURE EP™ Platform, it also relies heavily on the effectiveness of these partnerships. The success of this strategy will largely depend on the company's ability to secure and maintain strong relationships with established electrophysiology companies and distributors. This approach could enhance the company's scalability and reach, but it also introduces dependencies that may affect the control BioSig has over its sales and distribution channels.

Market Research Analyst

The integration of the PURE EP™ Platform with Near-Field Tracking (NFT) technology in leading medical centers and health systems is a noteworthy development. It highlights the platform's growing acceptance and potential to become a standard tool for electrophysiology procedures. The reported 66% reduction in ablation time, as presented by researchers from Cleveland Clinic, is a compelling value proposition that could drive adoption rates. However, the market will be watching closely to see if these clinical benefits translate into a competitive advantage and if they can be replicated across a broader user base. The focus on clinical support and the installation of the latest version of the software featuring NFT suggests that BioSig is committed to ensuring that their technology is not only adopted but also effectively utilized in clinical settings, which could further enhance the product's reputation and market share.

As BioSig quantifies the efficacy and safety benefits of NFT and explores expanded applications, it is essential for the market to monitor how these developments impact the company's market position. The ability to demonstrate tangible benefits and secure a niche in the electrophysiology market can be a key driver for the company's revenue growth and could potentially attract strategic partnerships or even acquisition interest from larger industry players.

Medical Device Analyst

The PURE EP™ Platform's technological advancement, particularly with its NFT algorithm, is a significant innovation in the field of intracardiac signal visualization. The ability to reduce ablation time is a critical factor in electrophysiology, as it can lead to improved patient outcomes and greater procedural efficiency. This technological edge must be supported by robust clinical data to ensure sustained adoption. The collaboration with early adopters and ongoing research into the efficacy and safety of NFT is a strategic move that can help BioSig maintain a competitive edge in the medical device market. However, the real-world performance and integration of the technology into existing clinical workflows will be a crucial determinant of its long-term success.

Investors should be aware of the challenges associated with the adoption of new medical technologies, including regulatory hurdles, the need for clinician training and the inertia of established treatment protocols. While the initial clinical findings are promising, broader peer-reviewed studies and long-term data will be essential to validate the technology's benefits and support widespread adoption. The company's efforts to integrate its hardware and software seamlessly into today's labs will be a key factor in its ability to gain market acceptance and drive growth.

• Cost Savings Targeted to Reduce Cash Burn by 50%

• Core Strategy Shifts to Business Development and Distribution Partnerships

Westport, CT, Jan. 30, 2024 (GLOBE NEWSWIRE) --  BioSig Technologies, Inc. (NASDAQ: BSGM) ("BioSig" or the "Company"), a medical technology company committed to delivering unprecedented accuracy and precision to intracardiac signal visualization, today announced a workforce reduction, intended to reduce annual cash burn by 50%.  The Company is reducing its internal workforce, which is expected to be completed by January 31. The Company is also shifting its business model and seeks to partner with organizations for sales distribution and clinical support of its PURE EP™ Platform.

"BioSig is at an important juncture, and we are taking steps to streamline our corporate structure. We are grateful to those employees who are affected by the impact of these changes. Their hard work and dedication were integral to bringing the PURE EP™ Platform to where it is today," said Ken Londoner, Chairman and CEO of BioSig.

Since its launch in Q4 2023, PURE EP™'s Near-Field Tracking (“NFT”) has increased customer interest and usage at some of the country's largest and leading medical centers and health systems. This usage has also illustrated the need for increased clinical support as the Company seeks to install its PURE EP™ Platform in additional accounts. The Company is looking to partner with well-established electrophysiology companies and distributors that already have clinical staff in the hospital setting.

"After a strategic review, we are adjusting the business model to ensure that we have an economical clinical infrastructure as we expand the recently released version 7 software featuring NFT," said Fred Hrkac, Executive Vice President of BioSig, who joined the Company on November 2, 2023. Mr. Hrkac has a 32-year career in medical device and electrophysiology business expansion for industry bellwethers.

Physicians from world-renowned medical centers, including Cleveland Clinic in Cleveland, OH, Mayo Clinic in Phoenix, AZ, Overland Park Regional Medical Center in Overland Park, KS, and Texas Cardiac Arrhythmia Institute in Austin, TX, have completed more than 100 cases using PURE EP™'s NFT algorithm.

Researchers from Cleveland Clinic presented topline clinical findings on the value of tissue-based science and methodology behind NFT at the Heart Rhythm 2023 convention held last May. Those findings evidenced a 66% reduction in ablation time when using the PURE EP ™ Platform, among other benefits.  Looking ahead, in collaboration with several early adopters, the Company is quantifying the efficacy and safety benefits of NFT and investigating expanded applications for the NFT software.

BioSig will continue to work closely with its physician partners to potentially integrate its hardware and software in today's labs to provide seamless functionality.

To learn more about PURE EP™'s growing suite of proprietary software-based features, click here.

About The PURE EP™ Platform
The PURE EP™ Platform serves physicians by enabling the real-time acquisition of raw cardiac signal data—absent of unnecessary noise or interference inherent in traditional approaches. By leveraging a first-of-its-kind combination of hardware and software, the PURE EP™ Platform is designed to deliver unprecedented intracardiac signal purity that pushes the boundaries of cardiac arrhythmia identification, diagnosis, and treatment.

In a blinded clinical study recently published in the Journal of Cardiovascular Electrophysiology^,1 electrophysiologists rated PURE EP™ as superior to conventional systems for 75.2% of signal samples, with 87% earning a rating of equivalent or superior. Data presented at Heart Rhythm Society 2023 demonstrated the PURE EP™ Platform's capacity to facilitate ablations in a third of the usual time, reducing procedure time and improving workflow efficiencies, without sacrificing accuracy, precision, or efficacy.

The PURE EP™ Platform is currently in a national commercial launch and an integral part of well-respected healthcare systems, including Cleveland Clinic, Mayo Clinic, Texas Cardiac Arrhythmia Institute, and Kansas City Heart Rhythm Institute.

About BioSig Technologies, Inc.
BioSig Technologies is a medical technology company focused on deciphering the body's electrical signals, starting with heart rhythms. By leveraging a first-of-its-kind combination of hardware and software, we deliver unprecedented cardiac signal clarity, ending the reliance on 'mixed signals' and 'reading between the lines.' Our platform technology addresses some of healthcare's biggest challenges—saving time, costs, and lives.

The Company's product, the PURE EP™ Platform, an FDA 510(k) cleared non-invasive class II device, provides superior, real-time signal visualization, allowing physicians to perform highly targeted cardiac ablation procedures with increased procedural efficiency and efficacy.

An estimated 14.4 million Americans suffer from cardiac arrhythmias, and the global EP market is projected to reach $16B in 2028 with an 11.2% growth rate^.2

Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) BioSig’s ability to regain compliance with and meet the continued listing requirements of the Nasdaq Capital Market to maintain listing of its common stock; (ii) the geographic, social, and economic impact of pandemics or worldwide health issues on BioSig’s ability to conduct its business and raise capital in the future when needed; (iii) BioSig’s inability to manufacture its products and product candidates on a commercial scale on its own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of BioSig’s competition; (vi) loss of one or more key executives or scientists; (vii) BioSig’s cost reduction plan and associated workforce reduction or other cost-saving measures not reaching the targeted reduction of cash burn by 50%; and (viii) difficulties in securing regulatory approval to market BioSig’s products and product candidates. For a discussion of other risks and uncertainties, and other important factors, any of which could cause BioSig’s actual results to differ from those contained in forward-looking statements, see Biosig’s filings with the Securities and Exchange Commission (“SEC”), including the section titled “Risk Factors” in BioSig’s Quarterly Report on Form 10-Q, filed with the SEC on November 14, 2023. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise, except as required by law.

---

^{1 Al-Ahmad, et al. (2022, September) Evaluation of a novel cardiac signal processing system for electrophysiology procedures: The PURE EP 2.0 study. https://onlinelibrary.wiley.com/doi/10.1111/jce.15250}

^{2 Cardiac Ablation Market. (2022, December). Global Market Insights. https://www.gminsights.com/industry-analysis/cardiac-ablation}

What is the ticker symbol for BioSig Technologies, Inc.?

The ticker symbol for BioSig Technologies, Inc. is BSGM.

What is the workforce reduction expected to achieve?

The workforce reduction is expected to reduce annual cash burn by 50%.

What is the business model shift for BioSig Technologies, Inc.?

BioSig is shifting its business model to partner with organizations for sales distribution and clinical support of its PURE EP™ Platform.

What benefits has the NFT algorithm of PURE EP™ shown?

The NFT algorithm has shown a 66% reduction in ablation time, among other benefits.

What is BioSig Technologies, Inc. looking to do with the NFT software?

The company is looking to expand applications and quantify the efficacy and safety benefits of the NFT software.