Nuwellis Archives - Medical Design Sourcing

Nuwellis, DaVita partner on ultrafiltration therapy pilot program

Nuwellis (Nasdaq:NUWE) announced today that it entered into a supply and collaboration agreement with DaVita (NYSE:DVA).

The agreement enables Nuwellis — formerly CHF Solutions — to pilot its Aquadex ultrafiltration therapy within selected U.S. markets. Aquadex, which removes excess fluid from patients suffering from hypervolemia (fluid overload), treats congestive heart failure and related conditions.

DaVita offers extracorporeal therapies like continuous renal replacement therapy and apheresis. The company recently launched a joint dialysis venture with Medtronic called “Mozarc Medical.”

Pairing Aquadex with DaVita’s care team could expand access to ultrafiltration therapy, Nuwellis said. The company also aims for this deal to reduce related healthcare costs for providers and payers.

“We are honored that DaVita is collaborating with Nuwellis to pilot a services model alongside Aquadex,” said Nestor Jaramillo, Jr., president and…

SeaStar Medical, Nuwellis partner on kidney injury treatment

SeaStar Medical’s Selective Cytopheretic Device (SCD) [Image courtesy of SeaStar Medical]SeaStar Medical (Nasdaq:ICU) and Nuwellis (Nasdaq:NUWE) today announced an exclusive U.S. license and distribution agreement.

Nuwellis agreed to market and distribute SeaStar’s selective cytopheretic device (SCD). The SCD treats acute kidney injury (AKI) in children. It selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop cytokine storm. The system works with continuous kidney replacement therapy (CKRT) to help the body return to homeostasis.

“We share a commitment with SeaStar Medical to bring potentially lifesaving therapies to children undergoing CKRT therapy,” said Nestor Jaramillo, Jr., Nuwellis president and CEO. “To this end, we are also currently developing a new, fully integrated pediatric CKRT device designed to provide care for small babies and children under 20 kg., and we remain committed to developing and bringing to mar…

Nuwellis announces compliance with Nasdaq listing requirements

Nuwellis (Nasdaq:NUWE) announced that it received notice from the Nasdaq market that it regained compliance with certain requirements.

Minneapolis-based Nuwellis last month received a 180-day extension from Nasdaq to regain compliance. That followed a 180-day period in which the company failed to do so.

Nasdaq granted the company time until May 29, 2023, to get its common shares to close at or above $1 for 10 consecutive business days. Shares of NUWE closed yesterday at $6.67 apiece. The market sent Nuwellis formal notice that it evidenced full compliance with the minimum bid price requirement.

The company advised that the matter is now closed, according to a news release.

About Nuwellis

Nuwellis has focused on developing, manufacturing, and commercializing its Aquadex SmartFlow system for ultrafiltration therapy. It formerly operated under the name “CHF Solutions.” The company rebranded to Nuwellis in April 2021.

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Nuwellis can’t get a quorum for shareholder vote

Nuwellis (Nasdaq:NUWE) announced today that it convened and adjourned its meeting of stockholders due to a failure to reach a quorum.

The fluid overload treatment developer held the meeting on Dec. 7 without any business conducted due to the lack of quorum.

Minneapolis-based Nuwellis develops the Aquadex SmartFlow system for ultrafiltration therapy. The company describes Aquadex SmartFlow as a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload).

Nuwellis said its quorum consists of one-third of the outstanding shares entitled to vote. Fewer than one-third of outstanding shares attended, either virtually or represented by proxy, at the special meeting. During the period of adjournment, the company intends to continue soliciting votes from its stockholders. This occurs with respect to the proposals set forth in its proxy statement.

Only Nuwellis stockholders as of the record date (Oct…

Nasdaq grants Nuwellis 180-day extension to comply with listing requirement

Nuwellis (Nasdaq:NUWE) announced today that the Nasdaq market granted it a 180-day extension to regain compliance.

Minneapolis-based Nuwellis must comply with the market’s minimum $1 bid price requirement for continued listing. The extension of 180 calendar days follows the expiration of its initial 180-day period to regain compliance on Nov. 28. As a result, Nuwellis now has until May 29, 2023, to regain compliance.

Should the bid price for Nuwellis common shares close at or above $1 for a minimum of 10 consecutive business days any time before May 29, 2023, it regains compliance. Nasdaq would provide written notification to the company confirming as much.

This notification has no immediate effect on the listing or trading of Nuwellis shares. They continue to trade under the NUWE ticker, according to a news release.

Shares of NUWE dipped 3.1% at 15¢ apiece during early-morning trading today. The company, whic…

Nuwellis appoints new CFO following $11M public offering

Nuwellis (Nasdaq:NUWE) today announced it appointed Lynn Blake as chief financial officer on news that it closed an $11 million underwritten public offering.

Blake’s appointment is effective immediately. She brings more than two decades of senior financial leadership to the Minneapolis-based company.

“Nuwellis is entering our next phase of commercial development with significant new opportunities in heart failure, pediatrics and critical care. The deep knowledge and experience in healthcare that Lynn brings will be instrumental as we advance our mission of bringing our Aquadex SmartFlow technology to more patients,” President and CEO Nestor Jaramillo, Jr. said in a news release. “Lynn’s medical device industry experience, combined with her strong financial leadership skills, makes her uniquely qualified for the next phase of our journey. I’m excited to welcome her to the team as we continue our dynamic growth.”

Most recently, she was a …

Nuwellis prices $9.6M upsized offering

Nuwellis (Nasdaq:NUWE) announced today that it priced an underwritten public offering worth approximately $9.6 million.

The Minneapolis-based fluid overload treatment developer formerly operated as CHF Solutions. Nuwellis is offering preferred stock, common stock and warrants.

It expects gross proceeds to total $9.6 million before deducting discounts, commissions and offering expenses, according to a news release.

The offering includes more than 15.2 million Class A units and more than 23.1 million Class B units. Nuwellis priced its Class A units at 25¢ apiece. Those feature one share of common stock and 1.5 warrants to purchase one share of common stock at 25¢ per share.

Class B units include one share of Series I convertible preferred stock, convertible into one share of common stock, and 1.5 warrants to purchase one share of common stock at 25¢ per share. Nuwellis priced the Class B units at 25¢ apiece, too.

Reverse stock split to come for …

Nuwellis posts Q2 sales beat

Nuwellis (Nasdaq:NUWE) shares were down today on second-quarter results that beat the consensus revenue forecast.

The Minneapolis-based fluid overload treatment developer — formerly known as CHF Solutions — posted losses of $4.3 million, or 41¢ per share, on sales of $2.2 million for the three months ended June 30, 2022, for a slight bottom-line gain while remaining in the red on a sales decline of 11.8%.

Nuwellis’ revenue totals topped expectations on Wall Street, where analysts were looking for sales of $2.1 million.

“I am very happy with our strong sequential performance in the quarter and remain encouraged by our considerable progress in executing our strategy to make the Aquadex System the standard of care for diuretic resistant patients needing fluid balance in the ICU or because of suffering from heart failure,” Nuwellis CEO Nestor Jaramillo said in a news release. “This includes securing reimbursement for outpatient ultrafiltration therapy,…

Nuwellis rises on Street-beating Q1

Nuwellis (Nasdaq:NUWE) shares ticked up today on first-quarter results that topped the consensus forecast.

The Minneapolis-based fluid overload treatment developer — formerly known as CHF Solutions — posted losses of $4.5 million, or 42¢ per share, on sales of more than $1.9 million for the three months ended March 31, 2022, for a bottom-line from losses of more than $5.2 million this time last year on sales growth of 0.4%.

Nuwellis’ losses per share of 42¢ came in 4¢ ahead of projections on Wall Street, where analysts were looking for sales of just shy of $1.8 million.

“I am very pleased with the resilient performance in the quarter,” Nuwellis CEO Nestor Jaramillo said in a news release. “Going forward, we expect to continue benefiting from the successful execution of our strategy and rollout of our new sales management system.”

Nuwellis did not provide 2022 guidance.

NUWE shares were up 7.7% at 75¢ per share in early-morning trading…

Nuwellis posts mixed bag Q4

Nuwellis (NSDQ:NUWE) shares were up today on fourth-quarter results that were mixed compared to the consensus forecast.

The Minneapolis-based fluid overload treatment developer — formerly known as CHF Solutions — posted losses of $4.4 million, or 41¢ per share, on sales of $1.6 million for the three months ended Dec. 31, 2021, for a bottom-line slide deeper into the red on a sales decline of 19.7%.

Nuwellis’ losses per share of 41¢ came in 7¢ ahead of expectations on Wall Street, where analysts were looking for sales of $2.1 million.

“We are encouraged by our progress executing our strategy throughout 2021. Our organization and its employees continued to show adaptability and resilience amid changing market conditions and customer requirements, and we ultimately succeeded in helping more patients benefit from our therapy during the year,” Nuwellis CEO Nestor Jaramillo said in a news release. “We anticipate that when this most recent omicron variant…

Nuwellis wins CE mark for 24-hour blood circuit set for use with Aquadex SmartFlow

Nuwellis (NSDQ:NUWE) announced today that it received CE mark approval for its 24-hour blood circuit set to be used with the Aquadex SmartFlow.

Eden Prairie, Minnesota-based Nuwellis — formerly CHF Solutions — can now market the 24-hour blood circuit set (UF 500-24 Hour) in the European Union and in other locations that recognize the CE mark.

According to a news release, the new device offers expanded access to ultrafiltration among patients who need no more than 24 hours of Aquadex therapy in the inpatient setting. Aquadex, a fluid management system that uses ultrafiltration to restore fluid balance in patients experiencing fluid overload, most recently received FDA 510(k) clearance for use in pediatric patients weighing 20 kg or more. Beyond treating heart failure, the device can be used in these situations with pediatric patients and in critical care.

The circuit can also provide a more economical solution for hospitals treating patients in the outpat…

MedTech 100 roundup: Return to normal following recent spike

After back-to-back all-time best performances, the medtech industry had a slight regression over the course of the last week.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been continuously ticking up since the beginning of April, with its mark of 112.25 on April 16 representing an all-time best, topping the previous high of 110.96 set on Feb. 15.

Just one week later, the index topped itself again, reaching 114.58 to end the week on April 23, marking an increase of 2.1% from the previous week. However, things have settled down and the industry responded in kind, dipping -1.6% to 112.7 to end last week (April 30).

In spite of the slight decrease over the past week, the industry continues to reflect a bounceback from the struggles brought on by the COVID-19 pandemic.

Overall, has produced a 22.1% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus an 81.4% increase from…