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ASCO: On Target-Made Fluorescent Marker Boosts Ovarian Cancer Surgery Chances



Ovarian Cancer

A fluorescent marker tool developed by On Target Laboratories boosts the ability of surgeons to find and remove cancerous lesions during surgical procedures, increasing progression free and overall survival. 

On Target’s pafolacianine sodium injection is a targeted fluorescent marker being assessed in a Phase III study as an adjunct to visual inspection and palpation through intraoperative imaging of folate receptor positive ovarian cancer.

The study found that 33% of procedures that included pafolacianine sodium injection identified one or more additional lesions that had not been revealed through current imaging practices. The number increased in patients underwent interval debulking surgery. For those patients, the discovery of additional lesions was found in 39.7% of patients.

Following a presentation at the virtual American Society of Clinical Oncology meeting Monday, Dr. Janos L. Tanyi, an Assistant Professor of Obstetrics and Gynecology in the Perelman School of Medicine at the University of Pennsylvania and Principal Investigator of the trial, told BioSpace in an exclusive interview touted the benefits of the fluorescent dye in finding these additional lesions in ovarian cancer patients.

“With this fluorescent agent, we were able to identify the additional lesions in these patients. If we had not, that means the patients might have walked out with some hidden cancer after the surgery,” Tanyi said. “This will be a very good tool for surgeons to use to help these patients.”

If pafolacianine sodium injection is approved for use by a regulatory agency, Tanyi said there would be a short learning curve for surgeons to use the agent. But, once they have used it a few times, he predicted the benefits for patients would significantly increase.

Ovarian cancer is the fifth leading cancer-related cause of death among women. The American Cancer Society estimates that in 2021 about 21,410 women in the United States will receive a new diagnosis of ovarian cancer and about 13,770 women will die from the disease.

In March, the U.S. Food and Drug Administration accepted the New Drug Application for pafolacianine sodium injection under Priority Review. The NDA is based on positive data from Phase II and Phase III studies. 

Data from the Phase II study found surgeons were able to detect additional lesions, regardless of tissue location, in 48.3% of patients were published in Gynecologic Oncology. Data from that study also found that pafolacianine sodium injection demonstrated a sensitivity of 97% when controlling for detection correlation of multiple lesions within a single patient.

The Phase III 006 open-label study included patients with ovarian cancer who were scheduled to undergo cytoreductive surgery in order to remove as much cancerous tissue in the patient’s abdomen as possible. The goal is to leave behind no tumor nodules that measure more than 1 centimeter in diameter. 

The fluorescent agent met the primary endpoint in a statistically significant percentage of patients whose folate receptor positive ovarian cancer lesion was detected by intraoperative fluorescence imaging on tissue not planned for resection and not detected by normal white light or palpation. 

Prior to the surgery, patients were infused with pafolacianine sodium injection to highlight folate receptors on the cancerous cells. Over 95% of ovarian cancers overexpress folate receptors to increase folate uptake for tumor growth. 

Special cameras using near-infrared light are then used to identify the agents in the abdominal cavity to help the surgeons remove the lesions. Tanyi said the agent’s highest concentration level in the cavity is about four hours after infusion but noted that it’s effective from about one hour after infusion up to 24 hours after. 

“This agent is a helpful tool in our hand to create a much better surgery,” he added. “It is a very big deal to be able to find additional lesions that would have been missed in one-third of patients.”

In addition to ovarian cancer, On Target is assessing pafolacianine sodium injection in the ongoing Phase III ELUCIDATE Trial in lung cancer. 

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Medical Devices

Sciton Celebrates the Newest Innovation in United Kingdom: Sciton’s mJOULE



Exceptional Outcomes Now Available Overseas

LONDON, June 18, 2021 /PRNewswire/ — Sciton® Inc., a leading manufacturer of medical and aesthetic lasers and light source technologies based in Palo Alto, California, announces the launch of its latest platform, mJOULE, in the United Kingdom. This revolutionary system features some of the biggest updates in the history of pulsed light based technology, including its newest fractional treatment, MOXI, and the award-winning BBL HERO treatment.

Sciton® Inc., announces the launch of its latest platform, mJOULE, which includes MOXI and BBL HERO in the UK.

“At Sciton, we work hand in hand with our clinician partners to drive visionary innovation that is founded on science and uncompromised quality,” shares Aaron Burton, Sciton CEO. “We are proud to be leading the industry with new product innovation and enhancements that benefit practices and patients alike.”

mJOULE is a dual wavelength platform that features BBL HERO and MOXI technologies, created in response to a changing market which desires less time consuming treatments, yet equally strong outcomes. Recently honored by NewBeauty as a 2020 ‘Innovation Award Winner,’ BBL HERO (High Energy Rapid Output) is the fastest, most powerful IPL in the industry, and empowers practitioners to treat the entire body with four times the speed, three times the peak intensity, allowing for a highly customizable protocol. The treatment results in smoother, clearer, younger and healthier looking skin in just one to two sessions.

“Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide.” says Lacee J. Naik, Vice President of Marketing and Public Relations.

The second technology available on the mJOULE platform is Sciton’s newest fractional laser, MOXI. MOXI is one of the most inclusive laser treatments available, and is safely suitable for those higher on the Fitzpatrick scale. This non-ablative laser addresses sun damage and aging, takes under 20 minutes and boasts little to no downtime, allowing it to fit comfortably into even the busiest of schedules and can be performed any time of the year.

“The U.K. is an important market for Sciton’s global growth strategy,” says David Percival, Vice-President and General Manager for Sciton International. “We see a tremendous opportunity to introduce both these novel technologies into the growing aesthetic market in the U.K. We have a strong reputation for delivering an outstanding customer experience and look forward to expanding our Sciton family of customers.”

Sciton will celebrate this monumental international launch with a premier event in London on June 24th, 2021, where staff, partners, and leadership will gather to recognize this milestone and officially welcome their ground-breaking technologies to the dynamic UK market.

Sciton, Inc., located in Palo Alto, California, is an employee-owned medical device company established in 1997 by co-founders Jim Hobart, Ph.D., and Dan Negus, Ph.D. Sciton is committed to providing best-in-class laser and light solutions for medical professionals who want superior durability, performance and value. Sciton offers aesthetic and medical devices for women’s health, fractional and full-coverage skin resurfacing and skin revitalization, phototherapy, vascular and pigmentation lesions, scar reduction, acne, body contouring, and hair reduction. Sciton operates on a worldwide basis with direct sales teams in the United States, Canada, Australia, United Kingdom, Ireland, Japan and distributor partners in more than 45 countries. For more information, and a complete listing of Sciton systems, visit

Facebook: @ScitonInc
Instagram: @Sciton_Inc
LinkedIn: @ScitonInc

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SOURCE Sciton, Inc.

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Avanos Medical, Inc. to Present at the 2021 Raymond James Human Health Innovation Conference



ALPHARETTA, Ga., June 18, 2021 /PRNewswire/ — Avanos Medical, Inc. (NYSE: AVNS) today announced that Joe Woody, chief executive officer, will present and participate in an analyst-led fireside chat at the Virtual 2021 Raymond James Human Health Innovation Conference Tues., June 22 at approximately 10:40 a.m., ET.

A live webcast of conference presentation will be available on the Investors section of the Avanos Medical website and will be archived on that site.

About Avanos Medical:
Avanos Medical (NYSE: AVNS) is a medical technology company focused on delivering clinically superior breakthrough medical device solutions to improve patients’ quality of life. Headquartered in Alpharetta, Georgia, Avanos is committed to addressing some of today’s most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Avanos develops, manufactures and markets its recognized brands in more than 90 countries. For more information, visit and follow Avanos Medical on Twitter (@AvanosMedical), LinkedIn and Facebook.

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SOURCE Avanos Medical

Company Codes: NYSE:AVNS

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Sequana Medical to Host a Key Opinion Leader Webinar on “The Impact of Liver Ascites on Patients and Healthcare Systems and the potential of alfapump® therapy in NASH-related ascites”



Live webinarwith Dr.Vargas and Dr. Knuttinenon15 July 2021at 4 pm CET / 10 am ET

GHENT, Belgium, June 17, 2021 (GLOBE NEWSWIRE) — Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces that it will host a Key Opinion Leader (KOL) call on July 15th, 2021 from 4 pm CET / 10 am ET to 5 pm CET / 11 am ET. The KOL call will discuss the impact of recurrent and refractory liver ascites on patients and healthcare systems and the potential of alfapump therapy in NASH-related ascites.

The webinar will feature a testimonial from a patient living with refractory ascites and treated with alfapump, followed by a presentation by KOLs Hugo E. Vargas, M.D. and Grace Knuttinen, M.D., Ph.D., both of Mayo Clinic, who will discuss the impact of ascites on the patients’ quality of life and the limitations of current treatment options. They will also share their experience with the alfapump implantation and discuss its potential in the treatment paradigm for these patients. A Q&A session with the KOLs and Sequana Medical management will follow the formal presentations.

Ascites is the most common reason for hospitalisation of patients with advanced liver disease and is forecast to grow dramatically driven by NASH-related cirrhosis. Sequana Medical’s alfapump has been granted FDA breakthrough device designation for the treatment of recurrent or refractory ascites due to liver cirrhosis.

The alfapump is a fully implantable pump system that moves ascites from the peritoneal cavity into the bladder, where it is passed naturally from the body through urination. The alfapump is approved in Europe and POSEIDON, the North American pivotal study to support regulatory approval in the US and Canada is underway. Positive interim data from the POSEIDON study were reported in November 2020 with further interim data expected in Q2 2021 and primary endpoint data in Q2 2022.

The webinar will be webcasted live at To get access to the webinar a registration in advance is required. The presentation and a replay of the webinar will be available on the website of Sequana Medical shortly after the event.

For more information, please contact:

Sequana Medical
Lies Vanneste
Director Investor Relations
Tel: +32 498 05 35 79

LifeSci Advisors
Guillaume van Renterghem
Tel: +41 76 735 01 31

About Dr. Vargas

Hugo E. Vargas, M.D. is a Mayo Clinic Consultant in the Department of Gastroenterology and Hepatology and the Mayo Clinic Transplantation Center. His current clinical and research interests include management of cirrhosis complications, acute chronic liver disease and alcohol related liver disease. Dr. Vargas is the Medical Director for the Office of Clinical Research – Arizona and a Professor of Medicine in the Mayo Clinic Alix School of Medicine and is the Chair of the Clinical Research Subcommittee, and the Vice Chair of the Arizona Research Operations Management Team. Dr. Vargas received his M.D. from Hahnemann University Graduate School of Medicine, has authored or coauthored more than 125 peer-reviewed articles and is a Fellow of the AASLD, AGA, ACG, ASGE and ACP.

About Dr. Knuttinen

Grace Knuttinen, M.D., Ph.D. is a Mayo Clinic Consultant and Professor in the Department of Radiology. She is an interventional radiologist with Mayo Clinic in Phoenix, with clinical and research interests in hepatobiliary disease, the management of post liver transplant complications, and vascular disease. Dr. Knuttinen has more than 20 years’ experience in interventional radiology and is a member of the Leadership Academy of the Society of Interventional Radiology and an Invited ABR Board Examiner for International Radiology at the American Board of Radiology. She is the Director for the Mayo Alix School of Medicine Dual Degree program, and the Director for the Barretts ASU- Mayo Alix School of Medicine Premedical Scholars program. Dr. Knuttinen received her M.D. and Ph.D. from Northwestern University, has coauthored over 95 peer-reviewed articles and written 13 book chapters. She is a Fellow of the Society of Interventional Radiology (SIR) and is the chair of a national SIR committee and currently the principal investigator of an ongoing national prospective funded clinical trial.

About Sequana Medical

Sequana Medical is a commercial stage medical device company utilizing its proprietary alfapump® and DSR® (Direct Sodium Removal) technologies to develop innovative treatments for fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a frequent complication of many large diseases including advanced liver disease driven by NASH (non-alcoholic steatohepatitis)-related cirrhosis and heart failure, with diuretic resistance being widespread. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for DSR and the alfapump DSR® is estimated to be over €5 billion annually in the U.S. and EU5 by 2026.

The alfapump is a unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination. DSR is Sequana Medical’s proprietary approach to managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.

In the U.S., the Company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA for recurrent or refractory ascites due to liver cirrhosis. Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints of the study. This study is intended to support a future marketing application of the alfapump in the U.S. and Canada. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 850 alfapump systems have been implanted to date.

Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure. RED DESERT, the repeated dose alfapump DSR study in diuretic-resistant heart failure patients has demonstrated that repeated DSR therapy is able to both manage the fluid and sodium balance of these patients as well as restore their diuretic response and improve their cardio-renal status. The SAHARA DESERT study of alfapump DSR in decompensated heart failure patients is ongoing.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit

Important Regulatory Disclaimers

The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see The DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR® therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

Note:alfapump® is a registered trademark. DSR® and alfapump DSR® are registered trademarks in the Benelux.

Forward-looking statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

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Avisa Diagnostics to Participate in Renmark’s Virtual Non-Deal Roadshow Series on June 17, 2021



SANTA FE, N.M., June 17, 2021 (GLOBE NEWSWIRE) — Avisa Diagnostics Inc. (CSE: AVBT) (Avisa), a clinical-stage medical device company developing an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of bacterial load in post-COVID-19 long haulers and for ventilator-associated pneumonia, announced today that the Company will participate in Renmark Financial Communications Inc.’s live Virtual Non-Deal Roadshow Series on June 17, 2021 at 12:00 PM ET.

Avisa Diagnostics’ President and CEO, David S. Joseph, will give a company presentation, followed by a live Q&A session. Investors interested in participating in this event will need to register using the link below. Registration for the live event may be limited, but access to a replay after the live event will be available on the Company’s website ( in the Investors section.


To ensure smooth connectivity, please access this link using the latest version of Google Chrome.

About Renmark Financial Communications Inc.

Founded in 1999, Renmark Financial Communications Inc. is North America’s leading retail investor relations firm. Employing a strategic and comprehensive mix of exposure tactics; Renmark hosts Virtual Non-Deal Roadshows as well as in-person corporate presentations and maintains daily communications with thousands of brokers and money managers across Canada and the United States. Renmark empowers its publicly-traded clientele to maximize their visibility within the financial community and strengthen their investor audience. For more information about Renmark and its events, please contact Scott Logan at, +1 (416) 644-2020 or +1 (514) 939-3989.

About Avisa Diagnostics Inc.

Avisa (CSE-AVBT) is a clinical-stage medical device company developing the Avisa BreathTest™, a novel drug/device biomarker technology platform that enables the ultra-rapid detection of virulent bacterial pathogens, detecting and monitoring bacterial load after the patient inhales or ingests its proprietary drug substrates. The Company has established clinical proof-of-concept through trials in cystic fibrosis, tuberculosis and community-acquired pneumonia, which demonstrated positive safety and clinical efficacy results. Avisa is planning pivotal trials in Post-COVID-19 bronchiectasis and ventilator-associated pneumonia and plans to submit Investigational Device Exemption applications to the U.S. FDA for these trials next year. For further information, visit and follow us on LinkedIn and Twitter.

Avisa Diagnostics Inc.
David S. Joseph
President and Chief Executive Officer
Phone: +1 610 947 0360

Investors and Media Contacts
MC Services AG
Laurie Doyle, Raimund Gabriel
Europe: +49 89-210 2280
U.S.: +1-339-832-0752

Forward-looking Statements

This press release contains statements which constitute “forward-looking information” within the meaning of applicable securities laws, including statements regarding the plans, intentions, beliefs and current expectations of the Company with respect to future business activities and operating performance. Forward-looking information is often identified by the words “may”, “would”, “could”, “should”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” or similar expressions and includes, but is not limited to, statements about the business plans and expectations of the Company and expectations for other economic, business, and/or competitive factors. Investors are cautioned that forward- looking information is not based on historical facts but instead reflects the Company’s management’s expectations, estimates or projections concerning future results or events based on the opinions, assumptions and estimates of management considered reasonable at the date the statements are made. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Resulting Issuer. Among the key factors that could cause actual results to differ materially from those projected in the forward-looking information are the following: (i) changes in general economic, business and political conditions, including changes in the financial markets, changes in applicable laws and regulations both locally and in foreign jurisdictions; (ii) compliance with extensive government regulation and the costs associated with compliance; (iii) the risks and uncertainties associated with foreign markets; and (iv) risks associated with the COVID-19 pandemic. This forward-looking information may be affected by risks and uncertainties in the business of the Resulting Issuer and market conditions. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated or expected. Although the Company has attempted to identify important risks, uncertainties and factors which could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended and such changes could be material. The Company does not intend, nor assume any obligation, to update this forward-looking information except as otherwise required by applicable law.

Neither the CSE nor its Market Regulator (as that term is defined in the policies of the CSE) accepts responsibility for the adequacy or accuracy of this release.

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