DIGNITANA RESPONDS TO AMERICAN MEDICAL ASSOCIATION DECISION REGARDING UNIQUE CPT CODE FOR SCALP COOLING
Lund, Sweden - 19 June 2018 - Dignitana AB, world leader in clinically superior scalp cooling technology, has responded to the announcement made earlier today by the American Medical Association (AMA), on their decision to reject the company's application to create a unique CPT® code for FDA-cleared automatic scalp cooling devices. The request, which was made at the May 2018 CPT Editorial Panel Meeting, was part of Dignitana's efforts to provide a pathway for a more universal and standardized patient coverage method. At present, the service of scalp cooling used in conjunction with patients' chemotherapy treatments for solid tumor cancers is not reflected in CPT nomenclature.
CPT® Codes, which are designated by the American Medical Association (AMA) and used to report medical, surgical, and diagnostic procedures and services to physicians, health insurance companies and accreditation organizations, are required by insurance companies (Third Party Payers) to correctly and consistently process claims for scalp cooling. Though Third Party Payers determine covered items within a specific patient plan, the creation of a CPT® Code provides a pathway for a more universal and standardized patient coverage method thereby providing greater access to this quality of life cancer care option nationwide.
"While we are disappointed with the outcome of our request to establish a new CPT code for scalp cooling which would have simplified the process for all parties involved, we respect the AMA's decision and will continue to provide the necessary documentation and data needed to aid in their future assessments," said William Cronin, CEO of Dignitana AB. "This decision does not change the increasing demand for scalp cooling by patients and we remain committed to working on behalf of all cancer patients to make access to this valuable therapy option easier and more affordable."
Until recently, hair loss was deemed an inevitable side effect of chemotherapy and continues to serve as an unwelcome reminder of the disease to cancer patients and their caregivers. An estimated 10 percent of patients decline prescribed chemotherapy out of fear of losing their hair, making greater accessibility and coverage of scalp cooling a vital component of cancer care.
Demand for scalp cooling grew exponentially across the U.S. following successful results from extensive, multi-center clinical trials and subsequent FDA clearances of the technology. The DigniCap® Scalp Cooling System was the first of its kind to be cleared by the FDA in 2015 for use by breast cancer patients and in July 2017 it became the first device to receive FDA clearance for use by patients with solid tumor cancers.
Dignitana will continue to work with the AMA on the complex process of creating a pathway to insurance coverage for scalp cooling and remains dedicated to its role as a market leader and advocate for improving comprehensive cancer care on a national scale.
This information is information that Dignitana AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, by the contact below, for publication at 1720 (CET) 19 June 2018
For more information contact:
William Cronin, CEO, Dignitana AB firstname.lastname@example.org +1 469 917 5555
Mikael Wahlgren, Deputy Managing Director, Dignitana AB email@example.com +46 709 33 72 20
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 Nasdaq First North Stockholm and has appointed Erik Penser Bank as Certified Adviser. Headquartered in Dallas Texas, Dignitana, Inc. is the U.S. subsidiary of Dignitana AB. DigniCap®is a patented scalp cooling system 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 acceptable patient comfort.
Sista dag för handel i Dignitanas betalda tecknade aktier, DIGN BTA, är tisdagen den 29 januari 2019. De nya aktierna beräknas att synas på VP-konton och depåer måndagen den 4 februari 2019.
Amendment - Last day of trading of paid-up shares in Dignitana AB (publ) is today, the 29 of January 2019
The last day of trading in Dignitana's paid-up shares, DIGN BTA, is Tuesday 29 January 2019. The new shares are estimated to be available in VP-accounts and depots Monday 4 February 2019.
Sista dag för handel i Dignitanas betalda tecknade aktier, DIGN BTA, är onsdagen den 30 januari 2019. De nya aktierna beräknas att synas på VP-konton och depåer måndagen den 4 februari 2019.
The last day of trading in Dignitana's paid-up shares, DIGN BTA, is Wednesday 30 January 2019. The new shares are estimated to be available in VP-accounts and depots Monday 4 February 2019.
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.