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DigniCap Delta receives TGA approval

Dignitana receives TGA approval for DigniCap Delta scalp cooling system in Australia
First deliveries planned for October

Dignitana AB, world leader in scalp cooling innovation, today announced that the Therapeutic Goods Administration (TGA) has cleared DigniCap Delta® for use by health care providers in Australia. The new device is the fourth generation of The DigniCap® Scalp Cooling System and is indicated to prevent chemotherapy-induced hair loss in patients with solid tumors.

“DigniCap Delta changes everything about the way scalp cooling is done today,” said William Cronin, CEO of Dignitana. “The Delta system improves the clinical process, reduces nursing intervention and optimizes patient outcomes. This new device, developed along with our partner sites, allows them to accomplish all three of these objectives. We are thrilled to offer patients and clinicians this state-of-the-art advancement in cancer care. Australia is a very important market for us and, as scalp cooling has become a standard of care for patients here, the Delta device will enable our partner sites to offer this valuable therapy option to more patients and much more efficiently.”

DigniCap Delta uses solid state cooling for precise temperature control in an advanced and redesigned model of the 2015 TGA cleared DigniCap Scalp Cooling System. The new device delivers significant improvements over other scalp cooling systems on the market:
• Single patient use New cap system provides each patient with a flexible Cooling Wrap and an adjustable Thermal Cap designed to optimize scalp cooling outcomes and minimize clinic storage needs.
• Smaller size Streamlined profile is 54 percent smaller than the previous unit.
• Reduced nursing time Intuitive interface means up to 80 percent reduction in nursing time per patient infusion versus the existing device.

DigniCap Delta is now available to hospitals in Australia through Dignitana’s longtime distribution partner, Aurora BioScience, with first deliveries expected in October.

Darren Banks, Managing Director of Aurora BioScience, stated “We are pleased that this approval comes at a time when both awareness of and demand for scalp cooling are rapidly increasing. We are expecting significant interest in the Delta system moving forward as it is a major improvement over existing systems currently on the market.”

For More Information Contact Dignitana Investor Relations +1 469 518 5031 investorrelations@dignitana.com

For customer enquiries in Australia and New Zealand please contact Aurora BioScience on 1300 309 994 or info@aurorabioscience.com.au

About Dignitana AB (publ)
Dignitana AB is the world leader in clinically superior scalp cooling technology. The company produces The DigniCap® Scalp Cooling System, a patented medical cooling device that offers cancer patients the ability to minimize hair loss during chemotherapy. FDA cleared since 2015, DigniCap provides continuous cooling with high efficacy, safety and patient comfort. Hailed internationally as a life-changing medical advancement for cancer patients, The DigniCap Scalp Cooling System was invented in 1996 by a Swedish Oncology nurse and has been available in Europe since 2001. Dignitana AB is listed on Nasdaq First North Growth Market in Sweden with headquarters in Lund, Sweden and operations based in Dallas, Texas in the United States. Company subsidiaries are Dignitana, Inc. in the United States and Dignitana S.r.l. in Italy. Learn more at www.dignitana.se and www.dignicap.com. Erik Penser Bank AB, Certified Adviser, +46 (0) 8 463 83 00 certifiedadviser@penser.se www.penser.se

About Aurora BioScience Pty Ltd

Located in Sydney Australia, Aurora BioScience is committed to providing advanced, high quality medical devices and healthcare products to assist medical professionals within Australia, New Zealand and the Pacific Islands healthcare markets.

Since 2005, our mission has been to contribute to the enhancement of patient’s quality of life while assisting to improve clinical outcomes.

Our areas of interest include cancer therapies, haematology and blood products as well neurology/neurosurgery.

For more information please go to www.aurorabioscience.com.au

Venous Leg Ulcers (VLU) and dermaPACE – Australian Experience

SANUWAVE Takes Next Step in Wound Care Expansion

SANUWAVE Health, Inc.

DERMAPACE TECHNOLOGY SUGGESTS PROMISING OUTCOMES OF ACOUSTIC PRESSURE SHOCKWAVE TREATMENT FOR VENOUS LEG ULCERS (VLU)

GLOBAL VLU MARKET SIZE SIMILAR TO DFU

SUWANEE, GA –  (NewMediaWire) – March 08, 2018 – SANUWAVE Health, Inc. (OTCQB: SNWV), an emerging medical technology company focused on the development and commercialization of noninvasive, biological response activating devices in regenerative medicine, announces the publication of research that investigated the use of the dermaPACE® System in the treatment of Venous Leg Ulcers (VLU) in a case study series.  The study, titled “Treating venous leg ulcers with Extracorporeal Shockwave Technology (ESWT)” by Charne Miller (LaTrobe University), Suzanne Kapp (University of Melbourne), Jade Green (LaTrobe University), William McGuiness (LaTrobe Alfred Health Clinical School), and Michael Woodward (Austin Health/University of Melbourne), appeared in Wounds International 2017, Volume 8 Issue 3.  The case series was implemented at a medical professional lead, multidisciplinary outpatient wound clinic in Melbourne, Australia.

The case study series consisted of 6 patients, meeting eligibility criteria, presenting with venous leg ulcers (VLU) and who agreed to receive the dermaPACE treatment.  In order to better understand wound response to dose and energy, treatment selection used the two highest energy settings on the dermaPACE System, delivered at a frequency of 240 pulses/min. The shockwave pulse count was a function of wound area (cm2) with larger wounds requiring more shockwaves for treatment and thus longer time per therapy session than smaller wounds. The protocol used recommended one treatment delivered each week for 10 weeks.

Positive wound healing effects were observed for the majority of patients receiving ESWT.  At the conclusion of the case series the majority of wounds were either healed or healing was anticipated in a subsequent visit.

For the full release please go to:

http://www.newmediawire.com/news/sanuwave-takes-next-step-in-wound-care-expansion-4821231

 

Memorial Sloan Kettering orders 17 DigniCaps®

Dignitana AB, the world leader in medical scalp-cooling technology, announced today that the DigniCap® scalp cooling system, which was cleared in December 2015 by the U.S. FDA to effectively reduce the likelihood of chemotherapy-induced hair loss in women with breast cancer, will be available at all Memorial Sloan Kettering Cancer Center (MSK) facilities that treat breast cancer.

The DigniCap® system is the first and only scalp-cooling device to receive FDA clearance. In the rigorous FDA clinical trial, seven out of ten patients with early-stage breast cancer kept at least 50% of their hair. The demand for the FDA-cleared DigniCap® system has been significant this year in the United States.

MSK, a world leader in cancer patient care, research, and educational programs, will now have the 17 units ordered in December of 2016 available for use by female patients undergoing breast cancer treatment in eight of their outpatient facilities in the New York Cityarea

 

http://www.prnewswire.com/news-releases/memorial-sloan-kettering-to-offer-dignicap-scalp-cooling-device-in-new-york-metro-area-locations-300405909.html

DigniCap for Breast Cancer patients in WA

Another update on the great success of our DigniCap Cooling System in Western Australia

Some comments:

“For the first 3 weeks after chemo & use of the DigniCap I didn’t experience any hair loss whatsoever. In fact, very surprisingly, my hair started to grow back! After 4 weeks of chemo, my hair was 8 millimetres long, & at the end of my chemo, 9 weeks later, my hair was 27 mm long!” – Belinda, 40, forensic scientist & avid cyclist, Perth

“Those entering our trial believe they will not only reap personal benefits, but will also be helping the next generaton of women undergoing chemotherapy” – – Prof Arlene Chan, Breast Medical Oncologists, Director Breast Clinical Trials Unit

For more information please go to

https://www.facebook.com/Ashley-and-Martin-Medical-Hair-Clinics-169747676432015/

BiaCare Compression Garments

SYDNEY, Australia. Aurora BioScience Pty. Ltd. today announced that it has entered into a sales and marketing distribution agreement for Australia and New Zealand with BiaCare, a leading provider of lymphoedema compression garments.

Aurora BioScience entered into a distribution agreement in December 2015; under the agreement Aurora Bioscience will be responsible for the sales, marketing, clinical support and distribution in both the Australian and New Zealand markets.

BiaCare is dedicated to helping meet the challenge of oedema with products that produce positive outcomes and improve the quality of life.

With well over 10 years of experience in manufacturing innovative compression garments, BiaCare is a diverse group of people, ranging from clinical professionals, engineers, marketing associates and design and production experts. All bring a unique set of talents to the table and share a common vision of providing the best therapeutic solutions available.

“The BiaCare range of compression garments are a truly innovative and important product line for the treatment of oedema, especially in the area of lymphoedema; these products have the potential to significantly improve the lives of patients” said Darren Banks, Managing Director of Aurora BioScience.

The BiaCare range includes compression garments for both lymphoedema and wound care, a full range of accessories as well as bandages, foams and other consumable items.

“We are extremely excited to be launching such an innovative and quality range in Australia and New Zealand and believe that the BiaCare products can have a significant impact on patient lives” stated Mr. Banks.

About Aurora BioScience Pty Ltd

Located in Sydney Australia, Aurora BioScience is committed to providing advanced, high quality medical devices and healthcare products to assist medical professionals within Australia, New Zealand and the Pacific Islands healthcare markets, to contribute to the enhancement of patient’s quality of life. Our areas of interest include lymphoedema, cancer therapies, neurology, pulmonology, and haematology and blood products.

For more information, please visit www.aurorabioscience.com.au

About BiaCare

The prefix “Bia” is of Greek origin and means “life”, similar to “Bio”. The name BiaCare captures, in a single word, the driving force of the company – to care about life. As we all know, life is full of physical challenges. BiaCare is dedicated to helping meet those challenges with products that produce positive outcomes, and improve the quality of life. BiaCare is located in Zeeland, Michigan, U.S.A.

www.biacare.com

DigniCap at Cabrini Brighton – A Patients Perspective

Aurora BioScience recently received a wonderful letter from a lady, Marie, who recently used the DigniCap at Cabrini Brighton in Melbourne. Please see her letter below. If you are a patient or medical professional who would like to contact Marie or want more information on how the DigniCap can assist you, please contact Aurora BioScience on 1300 309 994

Aurora Bioscience, NSW

23rd November 2015

Dear Annick,

I am writing to you to thank you and to say how lucky I am to be one of the few women to use the DigniCap Scalp Cooling System while undergoing chemotherapy at Cabrini Brighton.

In April this year I was diagnosed with Secondary Breast Cancer and was advised that the most suitable treatment plan was chemotherapy. Without sounding shallow or vain, when my oncologist was discuss the treatment, I did not think of the harmful effects that Chemotherapy was going to have on my body, the only thing I thought of was the fear of losing my hair.

When I went to visit the chemo ward of the hospital, the nurse ran through how the Dignicap will work when I come in for my treatment. At the time it was recently trialled with a group of women at Cabrini Brighton and there were very positive results. I was initially concerned on how I would tolerate the cold temperature on my scalp, but was prepared to try it if it could save my hair.

When I arrived for my first chemotherapy treatment, the nurses fitting the cool cap and began the process of cooling my scalp. After the initial 2-3 min of discomfort, described more like a “brain freeze” I was pleasantly surprised that this initial feeling subsided and was quite comfortable during the duration of the chemo therapy treatment.

After undergoing 17 sessions of chemotherapy in conjunction with the scalp cooling system, I am so thrilled with the results and the minimal impact on my hair. I am still able to have my hair blow-waved weekly and my hairstylist even said that he has seen my hair thicken and some areas.

It’s hard enough facing the devastating diagnosis of Breast Cancer and having to undergo chemotherapy. What is really exciting is that now this new amazing technology is available to help reduce the physical and psychological impact of this treatment. It is my belief and hope that this new technology is embraced by more hospitals and medical practices to support women going through this life changing time.

Kind Regards

Marie P

(Cabrini Brighton Hospital patient)

Dignitana at ASCO Chicago

Dignitana was present at the recent American Society of Clinical Oncology (ASCO) meeting in Chicago with the DigniCap® scalp cooling system taking centre stage.

A poster presentation entitled ‘Clinical Performance of the DigniCap® System, a Scalp Hypothermia System, in Preventing Chemotherapy Induced Alopecia – a multi centre trial” was extremely well received.

P177 Clinical Performance of the DigniCap System a Scalp Hypothermia System in Preventing Chemotherapy Induced Alopecia

In addition, NBC America aired a wonderful segment about our scalp cooling system DigniCap® – and the powerfully positive impact it can have on patients and their families. Here’s the clip: http://nbcnews.to/1FLq6Ly