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Like it or not, value-based contracting is coming for drugs and medical devices

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The way drugs and medical devices secure insurance coverage comes down to a series of negotiations. Suppliers of a product or a service typically try to set the highest possible price. Insurers try to knock those prices down, or they elect to cover a competing product instead. A new variable is entering the discussion: value-based agreements. These contracts tie the cost of a drug or device to how well a patient responds to treatment.

While linking the cost of care to patient outcomes seems simple in principle, it’s more complicated in practice. One reason that these contracts have been slow to gain widespread adoption is that the parties to the agreement are reluctant to let go of the old ways of striking these deals, said Francois de Brantes, senior vice president of Signify Health.

“Moving away from that isn’t simply a question of getting to value, but it’s fundamentally recognizing that you can no longer be the fundamental price setter that you are today and that you’re going to have to enter into a real negotiation about price,” he said. “And the price has to be commensurate to the value that you’re delivering.”

De Brantes spoke as a participant on an April 22 panel discussion on value-based contracting held during MedCity News’s INVEST conference. He was joined by Javier Gonzalez, chief growth officer of Abarca Health, and Jorge Galva, executive director of the Puerto Rico Health Insurance Administration.

Value-based agreements are structured very differently from the fee-for-service contracts that the industry has used. A value-based pact needs to define the outcomes that establish value, and that value must be sufficient to make the deal worthwhile to the parties involved, Gonzalez said. But these contracts can also yield additional benefit to the companies that are selling drugs and devices. A value-based agreement may be a differentiator that separates a company from competitors, or it may lead to faster adoption of new technologies, he added.

One place where value-based agreements are gaining traction in the pharmaceutical industry is the pricing of expensive new therapies for rare diseases. As an example, Gonzalez pointed to Zolgensma, a Novartis gene therapy for the rare disorder spinal muscular atrophy. The therapy won FDA approval in 2019. Though the price of the one-time treatment tops $2 million, Novartis can spread that cost over five years and it offers partial rebates if patients don’t meet clinical goals.

Making a value-based agreement work is an ongoing effort, according to Galva. The status of patients must be tracked over time, and these contracts require a great deal of information sharing. Signatories to such contracts must first define what will be measured and what the desired outcomes are. Without that clarity, it will be difficult to assess how successful a treatment is for a patient and whether a company has lived up to the contract’s terms.

“We hear about so many products that come out, both drugs and devices, that are supposed to be the greatest and best, and when we try them on people, the actual effect of the drug is only incrementally, marginally better than existing drugs or existing devices,” he said. “So we’re paying a whole boatload of money for this newfangled drug or device and we could have actually gone with the old one, which was much cheaper and tried, and the clinical results would have been more or less the same.”

Aligning incentives is something that has been challenging in putting together these contracts, Galva said. But he can point to some successes, such as a hepatitis C initiative in Puerto Rico. His agency, which runs the territory’s Medicaid program, assumed all of the risk of the hepatitis C medication’s cost. But the pharmaceutical company that markets the drug also provided Puerto Rico support with nurses, data collection, and screening of patients before and after treatment. Galva said that this support was important in achieving the desired patient outcome of a clinical cure.

Complexity is one of the reasons industry adoption of these contracts has been slow, according to Gonzalez. Getting to value-based agreements requires transparency in how prices are calculated, he explained. But right now, there isn’t sufficient transparency, so drug companies and payers aren’t finding common ground. Absent that, payers are inclined to forego value-based contracts altogether, he said. For value-based agreements to gain more acceptance, all parties must become more comfortable with risk—and that risk is shared. That’s hard for payers, who use actuarial science to form the predictive models that set premiums.

“Value-based arrangements right now are unpredictable,” Gonzalez said. “So you can see why maybe there’s a slowness to get there, because value-based agreements aren’t giving these health payers the predictability they need for their model.”

Success for any value-based contract depends on competition, de Brantes said. There is no reason for any entity—a drug or device maker, an insurer, a health system—to worry about value-based contracts if it has a monopoly.
Value-based payments and contracting should be a mechanism that accelerates market competition and drives toward better clinical outcomes at a reasonable price, he said.

Looming large over this evolving pricing environment is regulation. De Brantes noted that in some cases, these contracts are stymied by laws intended to prohibit the exchange of anything of value. What’s exchanged in these deals is information, but some statutes aren’t clear enough to take value-based contracts into account.

While the lack of clarity in some laws is a sticking point for forming value-based contracts, new regulations could be coming, and they might not be to the healthcare industry’s liking. De Brantes said that health industry incumbents have benefited from the status quo, but they must now show willingness to change how they do business or Congress will make those decisions for them. He pointed to policy proposals that politicians are debating about the cost of care.

“We’re leaning closer and closer to much more formal regulation of the industry,” de Brantes said. “And so I would say to all of the incumbents, like it or not, you have two choices: You either embrace the value-based payments and the value-based contracting world or you will face severe regulation.”


Public domain photo by Flickr user Government of Alberta

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Source: https://medcitynews.com/2021/04/like-it-or-not-value-based-contracting-is-coming-for-drugs-and-medical-devices/

Medical Devices

Windtree Therapeutics Reports First Quarter 2021 Financial Results and Provides Key Business Updates

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WARRINGTON, Pa., May 13, 2021 /PRNewswire/ — Windtree Therapeutics, Inc. (Formerly Known As Discovery Laboratories, Inc.), Inc. (NasdaqCM: WINT), a biotechnology and medical device company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today reported financial results for the first quarter ended March 31, 2021 and provided key business updates.

Key Business and Financial Updates

  • Expanded the participating countries and sites in the Company’s Phase 2 global clinical study of istaroxime for the treatment of Early Cardiogenic Shock in severe acute heart failure patients. Cardiogenic shock is a severe form of heart failure marked by critically low blood pressure. This study builds upon observations from the acute heart failure program and will assess the ability of istaroxime to improve blood pressure in these patients and is expected to be completed in the second half of 2021.
     
  • Dosed the first patient in its Phase 2 clinical trial studying lucinactant, the Company’s KL4 surfactant, in acute lung injury in adults with COVID-19 associated acute respiratory distress syndrome (ARDS). The study is designed to evaluate key safety and physiological measures and is expected to be completed in Q3 2021.
     
  • Completed an equity financing raising approximately $30.0 million in gross proceeds during the first quarter of 2021, before deducting underwriting discounts and commissions and other estimated offering expenses. Net proceeds from the offering were approximately $27.4 million.
     
  • Announced pursuit of additional expedited patent protection for our lead asset istaroxime with the filing of a Track One prioritized patent application with the U.S. Patent and Trademark Office for a patent stemming from an application previously filed under the Patent Cooperation Treaty. Under the Track One program, the new istaroxime patent is expected to receive review and final disposition within a year of priority status being granted, rather than the customary three-year examination for non-prioritized examinations.
     
  • Extended the scientific collaboration with the University of Milan-Bicocca for further characterization and development of the Company’s oral SERCA2a compounds for the potential treatment of chronic and acute human heart failure.

“With additional countries and sites opening and dosing patients in our Phase 2 global clinical study of istaroxime for the treatment of Early Cardiogenic Shock in severe acute heart failure patients and the first patient dosed in our Phase 2 study of lucinactant in acute lung injury in adults with COVID-19 associated ARDS, our first quarter was off to a very productive start,” said Craig Fraser, President and Chief Executive Officer of Windtree. “As we look to the rest of the year, we see several potential value-creating milestones with data readouts anticipated in both Phase 2 trials. Additionally, we are actively engaged on the business development front, and are encouraged by the level of interest. Importantly, with the successful completion of a financing this quarter, our balance sheet provides the runway to continue to help fuel these current and planned development activities. We are focused on execution and a year of important milestones.”

Select Financial Results for the First Quarter ended March 31, 2021

For the first quarter ended March 31, 2021, the Company reported an operating loss of $9.1 million, compared to an operating loss of $6.7 million in the first quarter of 2020.

Research and development expenses were $4.4 million for the first quarter of 2021, compared to $3.5 million for the first quarter of 2020. The increase in research and development expenses is primarily due to costs related to the clinical development of istaroxime.

General and administrative expenses for the first quarter of 2021 were $4.7 million, compared to $3.2 million for the first quarter of 2020.

The Company reported a net loss of $9.0 million ($0.51 per basic share) on 17.7 million weighted-average common shares outstanding for the first quarter ended March 31, 2021, compared to a net loss of $6.5 million ($0.48 per basic share) on 13.7 million weighted average common shares outstanding for the comparable period in 2020.

As of March 31, 2021, the Company reported cash and cash equivalents of $38.5 million.

Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, which will be filed with the Securities and Exchange Commission on May 13, 2021, which includes detailed discussions about the Company’s business plans and operations, financial condition, and results of operations.

About Windtree Therapeutics
Windtree Therapeutics, Inc. is advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders to treat patients in moments of crisis. Using new clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate istaroxime being developed as a first-in-class treatment for acute heart failure and early cardiogenic shock in heart failure. Windtree has also focused on developing AEROSURF® as a non-invasive surfactant treatment for premature infants with respiratory distress syndrome, and is facilitating transfer of clinical development of AEROSURF® to its licensee in Asia, Lee’s HK, while Windtree evaluates other uses for its synthetic KL4 surfactant for the treatment of acute pulmonary conditions including lung injury due to viral, chemical and radiation induced insults. Also, in its portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.

For more information, please visit the Company’s website at www.windtreetx.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include: risks and uncertainties associated with the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the Company’s clinical trials or disruption in supply chain; the success and advancement of the clinical development programs for istaroxime, AEROSURF®, KL4 surfactant and the Company’s other product candidates; the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, aerosol delivery systems (ADS) and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the FDA or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; and the rate and degree of market acceptance of the Company’s product candidates, if approved. These and other risks are described in the Company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Tables to Follow
+++++++++

Condensed Consolidated Balance Sheets

       

(in thousands, except share and per share data)

       
   

Three Months Ended

   

March 31,

   

2021

 

2020

   

Unaudited

   

ASSETS

       

Current Assets:

       

Cash and cash equivalents

 

$            38,490

 

$            16,930

Prepaid expenses and other current assets

 

851

 

1,188

Total current assets

 

39,341

 

18,118

         

Property and equipment, net

 

879

 

924

Restricted cash

 

154

 

154

Operating lease right-of-use assets

 

2,747

 

917

Intangible assets

 

77,090

 

77,090

Goodwill

 

15,682

 

15,682

Total assets

 

$          135,893

 

$          112,885

         

LIABILITIES & STOCKHOLDERS’ EQUITY

       

Current Liabilities:

       

Accounts payable

 

$                 939

 

$              1,161

Accrued expenses

 

3,744

 

3,813

Operating lease liabilities – current portion

 

392

 

805

Loans payable – current portion

 

2,409

 

352

Total current liabilities

 

7,484

 

6,131

         

Operating lease liabilities – non-current portion

 

2,438

 

201

Loans payable – non-current portion

 

 

2,423

Restructured debt liability – contingent milestone payments

 

15,000

 

15,000

Other liabilities

 

2,800

 

2,800

Deferred tax liabilities

 

16,683

 

16,778

Total liabilities

 

44,405

 

43,333

         

Stockholders’ Equity:

       

Preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding at March 31, 2021 and December 31, 2020

 

 

Common stock, $0.001 par value; 120,000,000 shares authorized at March 31, 2021 and December 31, 2020; 26,257,089 and 16,921,506 shares issued at March 31, 2021 and December 31, 2020, respectively; 26,257,065 and 16,921,482 shares outstanding at March 31, 2021 and December 31, 2020, respectively

 

26

 

17

Additional paid-in capital

 

821,165

 

790,277

Accumulated deficit

 

(726,649)

 

(717,688)

Treasury stock (at cost); 24 shares

 

(3,054)

 

(3,054)

Total stockholders’ equity

 

91,488

 

69,552

Total liabilities & stockholders’ equity

 

$          135,893

 

$          112,885

 

Condensed Consolidated Statements of Operations

       

(in thousands, except per share data)

       
         
   

Three Months Ended

   

March 31,

   

2021

 

2020

         

Expenses:

       

Research and development

 

$         4,410

 

$         3,461

General and administrative

 

4,669

 

3,242

Total operating expenses

 

9,079

 

6,703

Operating loss

 

(9,079)

 

(6,703)

         

Other (expense) income:

       

Interest income

 

50

 

89

Interest expense

 

(41)

 

(44)

Other income, net

 

109

 

124

Total other (expense) income, net

 

118

 

169

         

Net loss

 

$        (8,961)

 

$        (6,534)

         

Net loss per common share

       

Basic and diluted

 

$          (0.51)

 

$          (0.48)

         

Weighted average number of common shares outstanding

       

Basic and diluted

 

17,695

 

13,697

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SOURCE Windtree Therapeutics, Inc.

 

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Medical Devices

COBRA PzF NanoCoated Coronary Stent Demonstrates Exceptional Long-Term Safety and Low ID-TLR at Five Years in Highly Complex Patients Undergoing PCI

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SAN ANTONIO, May 13, 2021 /PRNewswire/ — CeloNova BioSciences, Inc. (CeloNova), a global medical device company that offers a family of innovative products based upon its proprietary Polyzene™-F nanocoating technology, today announced its flagship COBRA PzF NanoCoated Coronary Stent (NCS) achieved exceptional long-term ischemic safety of 0% definite and probable stent thrombosis (ST) and low ischemia-driven target lesion revascularization (ID-TLR) of 7.8% for its non-angiographic cohort at five years.1 Results conclude the company’s global, multicenter PzF SHIELD IDE clinical trial of highly complex patients undergoing percutaneous coronary intervention (PCI). The study met its primary and secondary endpoints at 9 months, demonstrating an excellent safety profile with 0% ST and low, 4.6% ID-TLR with a minimum of 1-month DAPT therapy and was the basis for the stent’s FDA approval in 2017.2,3

“It’s truly remarkable to have a stent achieve complete protection from ischemic events with 0% definite and probable stent thrombosis at both the 9-month and 5-year follow-up periods,” said Prof. Sigmund Silber, MD, PhD, Professor of Medicine FESC, FACC, FAHA at Practice in the ISAR Heart Center in Munich, Germany. “The results are particularly noteworthy given the highly complex nature of the patients who were studied. It offers valuable insight into COBRA’s performance as coronary artery disease progresses over time.”

A total of 296 patients with de novo coronary artery lesions from 35 centers across the U.S. and Europe received treatment with COBRA PzF NCS in the single-arm, non-randomized trial. The study’s population included elderly patients (66.5 average age) with co-morbidities including diabetes (33.7%), atrial fibrillation (12.2%) and those with highly complex lesions (72% with type B2 or C lesions).

“These results reinforce the unique thromboresistant, anti-inflammatory and rapid healing properties of COBRA’s proprietary Polyzene-F coating, which has been consistently demonstrated in my pre-clinical research at CVPath since 2012,” stated Aloke Finn, MD, Medical Director and Chief Scientific Officer at CVPath and Associate Professor of Medicine at the University of Maryland. “The results of the SHIELD trial show that there is a unique advantage of the Polyzene-F coating in allowing a stent to heal quickly and in a functional way without the need for antiproliferative drug elution. I believe COBRA will continue to play an important role in delivering safety and efficacy in real-world clinical practice over time.”

Over 25,000 patients worldwide have been treated to date with COBRA PzF NCS. The novel stent has been extensively evaluated over the course of 10 years and 10 clinical trials in roughly 3,300 patients worldwide, consistently demonstrating excellent results with exceptionally low ST, low TLR and with short DAPT regimens in a real-world patient population.4

“We are extremely pleased that COBRA PzF NCS continues to strike the perfect balance between safety and efficacy and proud of its durable long-term clinical outcomes,” stated Carl St. Bernard, President and Chief Executive Officer of CeloNova. “We look forward to continuing to evaluate its performance with ultra-short DAPT in the highly underserved patient population at high risk for bleeding.”  

COBRA PzF NCS is currently being evaluated with 14-days DAPT in high bleeding risk patients in the COBRA REDUCE clinical trial, the world’s first and only randomized, global 14-day DAPT study. The study’s six-month results, which were announced at TCT 2020, demonstrated strong ischemic performance of 0.6% definite and probable ST with just 14 days of DAPT with COBRA PzF NCS.  The company anticipates release of the study’s 12-month results later this year. 

About CeloNova BioSciences, Inc.

CeloNova BioSciences, Inc. is a global medical device company that develops, manufactures and markets a family of products based upon its novel Polyzene-F nanocoating technology. The next generation nanocoating is the result of years of rigorous scientific research and engineering and has been extensively published in numerous academic articles to date. For additional information about CeloNova, please visit our website at www.celonova.com.

The COBRA PzF NanoCoated Coronary Stent System is indicated for improving coronary luminal diameter in patients, including patients with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries. The COBRA PzF NanoCoated stent is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with reference vessel diameter (RVD) of 2.5-4.0mm and lesion length of ≤24mm. Click here for IMPORTANT SAFETY INFORMATION. Rx only. 

* AS DEMONSTRATED IN PRECLINICAL STUDIES. Correlation between bench testing, animal studies and humans have not been determined.
† The COBRA PzF NanoCoated Coronary Stent is not currently approved or indicated for high bleeding risk patients with 14-day DAPT.

  1. PzF SHIELD IDE Trial, 5-Year results, data on file at CeloNova BioSciences, Inc. Clinicaltrials.gov/ct2/show/NCT01925794.
  2. Cutlip D, Garrat K, Novack V, et al. 9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System. JACC Cardiovasc Interv. 2017;10(2):160-167.
  3. Levine G, Bates E, Bittl J, et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients with Coronary Artery Disease. Circulation. 2016;134(10):e123-55.
  4. ATLANTA FIM (n=55) TLR 3.6%, LST 0%; ATLANTA 2 Registry (n=300) TLR 6.5%, LST 0%; REVEAL OCT (n=34) Strut Coverage: PzF-97%, DES-90%, BMS-96%; ATLANTA FME Registry (n=500) TLR 4.3%, LST 0%; MAILLARD IIT (n=100) TLR 5%, ST 0%; UMEÅ IIT (n=103) TLR 3.9%, ST 0%; SHIELD at 5 Years (n=296) TLR 7.8% (non-angio subgroup), ST 0% (def/prob). 12% ID-TLR (angio + non angio subgroup).

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SOURCE CeloNova BioSciences, Inc.

 

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Medical Devices

Fuse Medical, Inc. Announces First Quarter 2021 Financial Results

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RICHARDSON, Texas–(BUSINESS WIRE)– Fuse Medical Inc. (OTCPINK: FZMD) (“Fuse” or the “Company”) an emerging manufacturer and distributor of innovative medical devices for the orthopedic and spine marketplace, announced that it has filed its quarterly report on Form 10-Q for the quarter ended March 31, 2021 with the Securities and Exchange Commission (“SEC”) on Wednesday, May 12, 2021.

First Quarter 2021 Financial Highlights

  • Net revenues for the quarter ended March 31, 2021 was $4.4 million, compared to $4.6 million for the quarter ended March 31 2020.
  • For the quarter ended March 31, 2021, gross profit was $2.6 million, or 58% of revenues, compared to $2.7 million, or 57% of revenues, for the quarter ended March 31, 2020.
  • Selling, general, administrative, and other expenses (“SG&A”) for the quarter ended March 31, 2021 declined by approximately $1 million or 42% to $1.4 million compared to $2.4 million for the quarter ended March 31, 2020.
  • Commissions expense for the quarter ended March 31, 2021 increased to $1.6 million from $1.4 million for the quarter ended March 31, 2020, an increase of approximately $200,000 of approximately 12%.
  • For the quarter ended March 31, 2021, net loss was $453,323 compared to $1,283,999 for the quarter ended March 31, 2020, reflecting a reduction in our net loss of $830,676 or approximately 65%.

Christopher C. Reeg, Chief Executive Officer of Fuse, commented “As we continue to navigate the COVID-19 pandemic, our first quarter of 2021 still felt the impact of elective surgery restrictions in several of our key markets. Despite this setback in January, coupled with the severe Texas Winter Storm in February that crippled Dallas and most of Texas, our Teams remained committed to our customers, and our elective case volumes are now trending above pre-pandemic levels. In light of these challenges, we have been successful in launching multiple new product lines, with several more launches scheduled throughout 2021. Q1 2021 also marked the beginning of our international expansion, with our first sales into the Australian marketplace.”

“We remain committed to growing our portfolio of innovative orthopedic and spinal devices, expanding our distribution footprint, and look forward to continuing this momentum throughout 2021 and beyond,” Mr. Reeg added.

First Quarter 2021 Highlights:

Highlights of Fuse’s first quarter 2021 include the following:

  • In January 2021, we entered into a marketing agreement with CarePICS Telehealth Platform to increase our wound care position.
  • In January 2021, we entered into an exclusive agreement with Orthovestments, LLC for the manufacturing and commercialization of the novel Orbitum™ Staple System, which increases our manufactured product portfolio. Initial Alpha launch of the Orbitum™ Staple System is slated for June 2021, with full commercial launch beginning early in Q3 2021.
  • In February 2021, we launched our Fuse ACP Anterior Cervical Plating System, expanding our offerings in our Spine division.
  • In March 2021, we fulfilled our first international sales order to a new Distributor partner in Australia, better positioning us to expand our business and sell our products globally.
  • We were successful in adding 7 new distributors during the three months ended March 31, 2021.
  • On May 4, 2021, we executed the Seventh Amendment to our Amended and Restated Business Lona Agreement with Amegy Bank, renewing our credit facility until November 4, 2021.

About Fuse Medical, Inc.

Fuse is an emerging manufacturer and distributor of innovative medical devices for the orthopedic and spine marketplace. We provide a comprehensive portfolio of products in the orthopedic total joints, sports medicine, trauma, foot and ankle space, as well as, degenerative and deformity spine, osteobiologics, wound care, and regenerative medicine products. For more information about the Company, or if you’re interested in becoming a distributor of any Fuse’s products, please contact us at info@fusemedical.com or visit: www.fusemedical.com.

Forward Looking Statements

Certain statements in this press release, constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend,” or similar expressions or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based only on information available to the Company as of the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the Securities and Exchange Commission; the failure of the Company to close the transaction; and integration issues with the consolidated company. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events, or otherwise, except as required by law.

FUSE MEDICAL, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in dollars, except share data)

             

 

 

March 31,

2021

 

 

December 31,

2020

 

 

 

(Unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

1,417,793

 

 

$

1,187,458

 

Accounts receivable, net of allowance of $618,771 and $787,766, respectively

 

 

3,487,710

 

 

 

4,427,896

 

Inventories, net of allowance of $3,315,541 and $3,077,728, respectively

 

 

7,594,969

 

 

 

6,981,413

 

Prepaid expenses and other current assets

 

 

94,536

 

 

 

24,203

 

Total current assets

 

 

12,595,008

 

 

 

12,620,970

 

Property and equipment, net

 

 

13,630

 

 

 

17,791

 

Long term accounts receivable, net of allowance of $2,707,228 and $2,615,834, respectively

 

 

1,750,478

 

 

 

1,669,510

 

Intangible assets, net

 

 

1,125,447

 

 

 

1,138,080

 

Goodwill

 

 

1,972,886

 

 

 

1,972,886

 

Total assets

 

$

17,457,449

 

 

$

17,419,237

 

Liabilities and Stockholders’ Equity (Accumulated Deficit)

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,325,107

 

 

$

3,236,592

 

Accrued expenses

 

 

2,696,806

 

 

 

2,584,734

 

Convertible notes payable – related parties

 

 

150,000

 

 

 

150,000

 

Payroll Protection Program Loan

 

 

361,400

 

 

 

361,400

 

Economic Injury Disaster Loan – short term portion

 

 

3,004

 

 

 

2,241

 

Senior secured revolving credit facility

 

 

1,088,352

 

 

 

913,352

 

Total current liabilities

 

 

7,624,669

 

 

 

7,248,319

 

Notes payable – related parties

 

 

200,000

 

 

 

200,000

 

Economic Injury Disaster Loan – long term portion

 

 

146,996

 

 

 

147,759

 

Earn-out liability

 

 

11,936,000

 

 

 

11,936,000

 

Total liabilities

 

 

19,907,665

 

 

 

19,532,078

 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity (accumulated deficit):

 

 

 

 

 

 

 

 

Preferred stock, $0.01 par value; 20,000,000 shares authorized, no shares issued and

outstanding

 

 

 

 

 

 

Common stock, $0.01 par value; 100,000,000 shares authorized, 73,124,458 shares issued and outstanding as of March 31, 2021 and December 31, 2020

 

 

731,245

 

 

 

731,245

 

Additional paid-in capital

 

 

1,300,170

 

 

 

1,184,222

 

Accumulated deficit

 

 

(4,481,631

)

 

 

(4,028,308

)

Total stockholders’ deficit

 

 

(2,450,216

)

 

 

(2,112,841

)

Total liabilities and stockholders’ equity (accumulated deficit)

 

$

17,457,449

 

 

$

17,419,237

 

                 

FUSE MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in dollars, except share data)

     

 

For the Three Months Ended March 31,

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

 

Net revenues

$

4,440,759

 

 

$

4,636,503

 

Cost of revenues

 

1,853,865

 

 

 

1,982,896

 

Gross profit

 

2,586,894

 

 

 

2,653,607

 

Operating expenses:

 

 

 

 

 

 

 

Selling, general, administrative and other

 

1,435,310

 

 

 

2,480,771

 

Commissions

 

1,564,753

 

 

 

1,391,117

 

Depreciation and amortization

 

16,794

 

 

 

29,983

 

Total operating expenses

 

3,016,857

 

 

 

3,901,871

 

Operating loss

 

(429,963

)

 

 

(1,248,264

)

Other expense:

 

 

 

 

 

 

 

Interest expense

 

19,000

 

 

 

31,001

 

Total other expense

 

19,000

 

 

 

31,001

 

Operating loss before tax

 

(448,963

)

 

 

(1,279,265

)

Income tax expense

 

4,360

 

 

 

4,734

 

Net loss

$

(453,323

)

 

$

(1,283,999

)

Net loss per common share – basic and diluted

$

(0.01

)

 

$

(0.02

)

Weighted average number of Common Stock outstanding – basic and diluted

 

70,221,566

 

 

 

70,221,566

 

               

FUSE MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

       

 

 

For the Three Months Ended March 31,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(453,323

)

 

$

(1,283,999

)

Adjustments to reconcile net loss to net cash provided by operating

activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

16,794

 

 

 

29,983

 

Share-based compensation

 

 

115,948

 

 

 

162,656

 

Provision for bad debts and discounts

 

 

 

 

 

417,219

 

Provision for long term accounts receivable

 

 

91,394

 

 

 

198,124

 

Provision for slow moving inventory

 

 

237,813

 

 

 

81,190

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

940,186

 

 

 

1,639,955

 

Inventories

 

 

(851,369

)

 

 

(27,267

)

Prepaid expenses and other current assets

 

 

(70,333

)

 

 

(77,520

)

Long term accounts receivable

 

 

(172,362

)

 

 

(495,310

)

Accounts payable

 

 

88,515

 

 

 

(181,162

)

Accrued expenses

 

 

112,072

 

 

 

(539,973

)

Net cash provided by (used in) operating activities

 

 

55,335

 

 

 

(76,104

)

 

 

 

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

 

 

 

(20,757

)

Net cash (used in) investing activities

 

 

 

 

 

(20,757

)

 

 

 

 

 

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

 

 

 

Net payments/proceeds on senior secured revolving credit facility

 

 

175,000

 

 

 

(249,181

)

Net cash provided by (used in) financing activities

 

 

175,000

 

 

 

(249,181

)

 

 

 

 

 

 

 

 

 

Net increase (decrease) in cash

 

 

230,335

 

 

 

(346,042

)

Cash and cash equivalents – beginning of period

 

 

1,187,458

 

 

 

1,099,310

 

Cash and cash equivalents – end of period

 

$

1,417,793

 

 

$

753,268

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

10,000

 

 

$

21,788

 

                 

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Source: https://www.biospace.com/article/releases/fuse-medical-inc-announces-first-quarter-2021-financial-results/?s=93

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DOORwaY-90 Study for SIR-Spheres® Therapy as 1st-line Treatment for Hepatocellular Carcinoma Enrolls First Patient

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DOORwaY-90 Study: Sirtex Medical (“Sirtex”), a leading manufacturer of targeted liver cancer therapies, announced that the first patient has been enrolled in DOORwaY90, a study evaluating the safety and efficacy of selective internal radiation therapy (SIRT) using SIR-Spheres® Y-90 resin microspheres in patients with unresectable hepatocellular carcinoma (HCC).

DOORwaY90, which stands for “Duration of Objective Response with Arterial Y-90,” is the first prospective, U.S.-based multicenter, open-label single arm study of its kind. The study will assess the duration of response (DoR) and objective response rate (ORR) of SIR-Spheres. It is being led by co-principal investigators Cheenu Kappadath, PhD and Dr. Armeen Mahvash. Study enrollment is underway, with the first patient enrolled at Inland Imaging Associates and Providence Sacred Heart Medical Center in Spokane, Washington.

“We are thrilled to enroll the first patient in DOORwaY90,” said Dr. Mark A. Turco, Global Chief Medical Officer and EVP of Research and Development for Sirtex. “This clinical trial studying a heterogeneous population of patients with HCC using personalized dosimetry planning has the potential to advance the treatment of HCC patients worldwide. We are deeply thankful to every clinical investigator and patient who will be part of this groundbreaking journey.”

With a planned enrollment of 100 subjects across 15 sites both academic and non-academic, DOORwaY90 is enrolling patients with Barcelona Clinic Liver Cancer (BCLC) Stage A, B1 and B2 who are not eligible for resection or ablation at the time of study entry. The study is unique because it is the first FDA-approved U.S.-based prospective trial to utilize and delineate personalized dosimetry treatment planning and to define actionable post-treatment dosimetric verification for endpoint assessment.

“It’s important for physicians to have confidence that their planned Y-90 dose is being delivered in the right amount and to the right place,” said Dr. Douglas Murrey, Vascular and Interventional Radiologist at Inland Imaging Associates and Providence Sacred Heart Medical Center in Spokane, Washington. “The personalized dosimetry component of the DOORwaY90 study will provide meaningful insights to advance our practice and patient outcomes.”

HCC is often diagnosed when potentially curative resection or transplantation is not feasible. SIRT has the potential to deliver a lethal dose of radiation to hepatic tumors, while sparing surrounding healthy liver tissue. In countries outside the U.S., SIRT has been successfully used to bridge patients to transplantation or downstage HCC to within transplantation criteria or resection.

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Source: https://infomeddnews.com/doorway-90-study/

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