Memorial Sloan Kettering to offer Dignicap® scalp cooling device in New York metro area locations
Dignitana AB, a 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 City area. These include MSK Basking Ridge and MSK Monmouth, in New Jersey; MSK Westchester, in Westchester County, New York; and MSK Commack and MSK Rockville Centre, on Long Island, in addition to their Manhattan and Brooklyn locations.
"Scalp cooling is clinically proven and can be an important tool for many women in treatment for breast cancer," says Mario Lacouture, MD, Director of the Oncodermatology Program at MSK. "As a world leader in comprehensive cancer care, we are proud to be able to offer our patients across the New York metro area this new FDA-cleared advancement that addresses one of the most distressing and most visible side effects of chemotherapy."
"Bringing the DigniCap® system to MSK is an important milestone for Dignitana," says William Cronin, Chief Executive Officer of Dignitana, Inc., the U.S. subsidiary of Dignitana AB. "We have just passed the one-year anniversary of clearance by the FDA for DigniCap® in the U.S., and we are proud to add Memorial Sloan Kettering, one of the top comprehensive cancer centers in the U.S., to the growing number of facilities that are providing this treatment option to patients on a large scale."
The DigniCap® clinical team is working directly with the clinical practitioners at each of the eight MSK sites to train and certify staff on the machine. This is the largest scalp-cooling installation at any medical center to date in the U.S. Nearly 100 nurses and other medical personnel will be trained in preparation for the launch of this service at MSK in the Spring of 2017.
The DigniCap® scalp cooling system features a patented tight-fitting silicone cooling cap that is placed directly on the head, and an outer neoprene cap that insulates and secures the silicone cap. The cooling cap is connected to a cooling and control unit with touch-screen prompts. A liquid coolant circulates throughout the silicone cap, delivering consistent and controlled cooling to all areas of the scalp. The cap is fitted to the head, and the temperature of the scalp is lowered, resulting in vasoconstriction with reduced delivery of chemotherapy to the scalp, as well as reduced cellular uptake of drugs due to decreased intra follicular metabolic rate. These factors together reduce the risk of chemotherapy-induced hair loss.
Lund, Sweden - February 13, 2017
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About Dignitana AB (publ)
Dignitana is a Swedish public company, based in Lund, and manufacturer of the medical cooling device DigniCap®. Dignitana AB is listed on the OMX Nasdaq First North stock exchange and has appointed Erik Penser Bank as Certified Advisor. Headquartered in Dallas, Texas, Dignitana, Inc. is the U.S. subsidiary of Dignitana AB. For more information visit www.dignitana.com.
About Memorial Sloan Kettering
We are the world's oldest and largest private cancer center, home to more than 14,000 physicians, scientists, nurses, and staff united by a relentless dedication to conquering cancer. As an independent institution, we combine 130 years of research and clinical leadership with the freedom to provide highly individualized, exceptional care to each patient. And our always-evolving educational programs continue to train new leaders in the field, here and around the world. For more information, go to www.mskcc.org.
Teckningsperioden för Dignitana ABs ("Dignitana" eller "Bolaget") nyemission med företrädesrätt för Bolagets aktieägare löpte ut den 18 december 2018. Företrädesemissionen omfattades av teckningsförbindelser och garantiåtaganden upp till 100 procent av det totala emissionsbeloppet, som högst kunde uppgå till ca 24,3 MSEK. Utfallet visar att 5 383 686 aktier, motsvarande cirka 93 procent av Företrädesemissionen, tecknades med stöd av teckningsrätter och att 408 917 aktier, motsvarande cirka 7 procent av Företrädesemissionen, tecknades utan stöd av teckningsrätter. Totalt tecknades 1 517 201 aktier utan företrädesrätt innebärande att företrädesemissionen tecknades till ca 119 procent. Genom företrädesemissionen tillförs Bolaget ca 24,3 MSEK före emissionskostnader. Emissionsgarantin har inte tagits i anspråk.
The subscription period for Dignitana AB's ("Dignitana" or "the Company") rights issue with preferential right for the Company's shareholders ended on 18 December 2018. The rights issue was covered by subscription commitments and guarantees up to 100 percent of the total amount in the Issue, corresponding to approximately SEK 24.3M. 5,383,686 shares, corresponding to 93 percent of the rights issue, was subscribed for with subscription rights and 408,917 shares, corresponding to approximately 7 percent of the rights issue, was subscribed for without subscription rights. In total, 1,517,201 shares were subscribed for without subscription right, implying that the rights issue was subscribed for to approximately 119 percent and the Company will receive approximately SEK 24.3M before issue costs. There will be no need to utilize the guarantee obligations that have been provided.
Dignitana och ThermoTek har slutit avtal om kontraktsutveckling och produktion av nästa generations skalpkylningssystem
DigniCap Delta bygger på en avancerad kylteknik som minimerar håravfall vid kemoterapi
Dignitana AB, som tillverkar DigniCap® skalpkylningssystem, inleder ett samarbete med ThermoTek, Inc. för att utveckla DigniCap Delta, en avancerad modell av det FDA-godkända skalpkylningssystemet DigniCap från 2015. Den nya versionen är en mindre och smidigare enhet för behandling av en patient åt gången med en nydesignad, engångskylmössa.
FDA-godkännande för den nya enheten väntas komma under våren 2019.
DigniCap Delta brings advanced cooling technology to minimize hair loss from chemotherapy
Dignitana AB, manufacturer of The DigniCap® Scalp Cooling System, has partnered with ThermoTek, Inc. to develop the DigniCap Delta, an advanced model of the 2015 FDA-cleared DigniCap Scalp Cooling System, featuring a new single-patient use cap design and a smaller, more streamlined single-patient machine. U.S. Food and Drug Adminstration clearance for the new device is anticipated in spring 2019.
Styrelsen i Dignitana AB (publ) har idag beslutat, pga stort intresse, komplettera den tidigare aviserade riktade emissionen, genom att emittera ytterligare 540 000 aktier till ett belopp om 2,3 MSEK. Sammantaget innebär detta att de riktade emissionerna omfattar totalt 9,5 MSEK.
Dignitana complements the previously announced directed rights issue - decides on an additional directed rights issue
The Board of Directors of Dignitana AB (publ) has decided today, as a result of a large investor interest, to complement the previously announced directed rights issue by emitting 540,000 additional shares to an amount of approximately SEK 2.3M. In total this implies that the directed rights issues comprise a total of SEK 9.5M.
Styrelsen i Dignitana AB (publ) offentliggör härmed ett Informations-Memorandum med anledning av förestående företrädesemission. Memorandumet finns nu tillgängligt på bolagets hemsida, www.dignitana.se.
The Board of Directors of Dignitana AB (publ) hereby publishes an Information Memorandum on the announced rights issue. The Information Memorandum is attached here and is published today on the Company's webpage,www.dignitana.com.
Results and financial position
Significant events during the period
- Sales for the period amounted to 10,293 TSEK, $1,150 KUSD, an increase of 125 percent compared to the same period in 2017 and an increase of 14 percent compared to the second quarter 2018.
- EBITDA amounted to (3,459) TSEK, ($386 KUSD), a 56 percent improvement compared to the same period in 2017.
- 6 units were sold to facilities in countries outside the U.S.
- Contracts for 7 locations in the U.S. were signed.
- Third quarter treatment revenue in the U.S. increased over second quarter 2018.
- In July Dignitana AB registered a new wholly-owned subsidiary, Dignitana S.r.l (Società a responsabilità limitata), as a new Italian entity to facilitate contracting with public health facilities in Italy.
Significant events after the period
- Contracts for 10 locations in the U.S. have been signed since 30 September.
- 8 units sold outside the U.S. since 1 October 2018.
- On 8 October Dignitana announced that Mr. Greg Dingizian, via his Adma Förvaltnings AB investment vehicle, has accumulated a 4,200,000 share position in the company. The share purchases of Adma Förvaltnings AB represent 10.4 percent of the outstanding common shares of the company.
- An agreement has been reached with Konica-Minolta and Beijing University Cancer Hospital to perform a limited usage trial of the DigniCap device to evaluate efficacy when compared to manual gel caps. The trial is scheduled to begin during the fourth quarter 2018.
The company has announced a combination of a directed equity and rights issue to obtain 30 MSEK. This transaction is scheduled to be completed by mid-December.
Dignitana AB (publ) genomför nyemissioner om cirka 31,6 MSEK fördelat på en riktad nyemission om ca 5.8 MSEK, en fullt garanterad företrädesemission om 24,3 MSEK samt ytterligare en riktad emission genom kvittning av garantiersättning om cirka 1,4 MSEK
Dignitana AB to carry out new issues of approximately SEK 31.6M in a directed issue of approximately SEK 5.8M, a fully guaranteed rights issue of SEK 24.3M with preferential right for existing shareholders and another directed rights issue offsetting the guarantee fee of approximately SEK 1.4M.