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…

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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…

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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…

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CHF Solutions changes name, broadens focus

CHF Solutions announced that it changed its name to Nuwellis to reflect its focus on pediatric care, critical care and heart failure fluid imbalance.

Eden Prairie, Minn.-based Nuwellis made the change effective on Tuesday, April 27, 2021, and, in conjunction with the name change, changed its ticker symbol on the Nasdaq from CHFS to NUWE, according to a news release.

Nuwellis is meant to be a reflection of the “new well” that the company believes signifies “better tomorrows” for patients, families and providers through the benefits of the company’s Aquadex system.

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 of use in these situations with pediatric patients and in critical care, Nuwellis said.

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CHF Solutions prices $18.1M offering

CHF Solutions (NSDQ:CHFS) announced today that it priced an underwritten public offering of common stock worth $18.1 million.

Eden Prairie, Minn.-based CHF Solutions is offering more than 3.3 million shares of its common stock to the public at $5.50 per share, totaling the $18.1 million expected in proceeds before deducting underwriting discounts and commissions and offering expenses payable by the company, according to a news release.

CHF Solutions also granted underwriters an option, exercisable in whole or in part for 45 days, to purchase up to an additional 495,106 shares at the public offering price.

The company expects the offering to close on or about March 19, with the proceeds earmarked for general corporate purposes, including investment in commercialization efforts. CHF Solutions develops the Aquadex SmartFlow consoles for removing excess fluid from patients suffering from hypervolemia (fluid overload).

Ladenburg Thalmann …

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CHF Solutions closes $14.4M offering

CHF Solutions (NSDQ:CHFS) announced that it closed an underwritten public offering worth gross proceeds of approximately $14.4 million.

Eden Prairie, Minn.-based CHF Solutions’ offering includes the full exercise of the underwriters’ over-allotment option to purchase additional shares and warrants, bringing the total proceeds to $14.37 million after the offering was priced last week at approximately $12.5 million.

The company offered nearly 27.8 million units comprised of one share of common stock and one warrant to purchase one share of common stock at a public offering price of 45¢ per share, which expires on the fifth anniversary of the date of issuance. The over-allotment included nearly 4.2 million more shares of common stock and additional warrants to purchase that amount of shares.

In total, CHF Solutions issued more than 31.9 million shares of common stock and warrants to purchase up to that amount, with the securities comprising the …

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CHF Solutions prices $12.5M offering

CHF Solutions (NSDQ:CHFS) announced today that it priced an underwritten public offering of units worth approximately $12.5 million.

Each unit in the offering consists of one share of common stock and one warrant to purchase one share of common stock at a public offering price of 45¢ per share, which expires on the fifth anniversary of the date of issuance, according to a news release.

In total, the Eden Prairie, Minn.-based company is offering nearly 27.8 million units at the public offering price, bringing the expected gross proceeds to $12.5 million, prior to deducting underwriting discounts, commissions and offering expenses payable by the company.

Additionally, underwriters were granted a 45-day option to purchase up to nearly 4.2 million more shares of common stock and additional warrants to purchase that amount of shares, solely to over over-allotments, if any. CHF Solutions expects the offering to close on or about Aug. 21.

Ladenburg Thalm…

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MedTech 100 roundup: Another high as stocks tick up

For the third consecutive week, stocks in the medtech industry reached heights not yet seen since the COVID-19 pandemic began.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.65 points at the end of last week (Aug. 7). Overall, medtech stocks saw a 0.72% increase from the 89.01-point total at the same time a week prior (July 31).

On Aug. 5, the index reached 90.45 points, marking its highest point since that pre-pandemic high, with the previous mid-pandemic high (90.37) coming last week.

The most recent high mark represents just a -2% dip from the Feb. 19 high point of 92.32, marking the smallest margin of decline over the past five months.

Meanwhile, the S&P 500 Index saw a 2.5% increase from July 31 to Aug. 7, and the Dow Jones Index fared even better, positng a 3.8% rise over the same period of time.

Medtech’s lowest point during the COVID-19 pandemic remains at 62.13…

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CHF Solutions sales up 11% in Q2 amid increased COVID-19 demand

CHF Solutions (NSDQ:CHFS) shares took a hit today despite second-quarter revenues that received a boost amid the COVID-19 pandemic.

The Eden Prairie, Minn.-based fluid overload treatment developer posted losses of -$3.9 million, or -10¢ per share, on sales of $1.9 million for the three months ended June 30, 2020, for an 11.5% bottom-line gain on sales growth of 11.1%.

CHF Solutions got that sales boost in part due to increased demand in its Aquadex SmartFlow consoles for removing excess fluid from patients suffering from hypervolemia (fluid overload), which was related to treating patients with COVID-19.

In April, the company announced that it had doubled its production staff to cope with the heightened demand for the consoles.

“We continue to be very pleased that we produce a product that is providing a meaningful therapy for treating the COVID-19 patients,” CHF Solutions chairman & CEO John Erb said in a news release. “We know we are very fo…

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CHF Solutions announces new president, COO

CHF Solutions (NSDQ:CHFS) recently announced that it has promoted Nestor Jaramillo Jr. to the president and COO spot at the company.

Jaramillo’s promotion was effective July 1.

Jaramillo has been at the Eden Prairie, Minn.-based fluid overload treatment developer since May 2019, focusing on commercial growth.

“Nestor has had a strong impact on our commercial success over the last 14 months,” said CHF Solutions CEO John Erb.

“Under Nestor’s leadership, we have expanded our strategy into critical care and pediatrics, including the recent launch of the Aquadex SmartFlow system for use in adult and pediatric patients weighing over 20 kg. I look forward to continuing to work with Nestor as the company improves the lives of patients suffering from fluid overload,” Erb said in a June 25 news release.

Before CHF, Jaramillo was president and CEO of Innerspace Neuro Solutions, a commercial-stage medtech company that developed, manufacture…

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