Positive feedback from treatment with SpectraCure’s system Q-PRO® in New York
Thu, Feb 02, 2023 14:40 CET
In the ongoing clinical study, the first treatment with the new generation of SpectraCure's system Q-PRO® with integrated image processing technology was performed in November. The procedure went according to plan, and the system met the highly set expectations. Dr. James A. Eastham is the investigator at MSKCC in New York and the first Doctor to use the new generation of SpectraCure’s Q-PRO® treatment system in the clinical study. Dr. Eastham is a surgeon who specializes in nerve-sparing prostatectomy for the treatment of prostate cancer and salvage radical prostatectomy in patients with prostate cancer in whom radiation therapy has failed. The company has received positive feedback regarding the usability of SpectraCure’s Q-PRO® system after the first treatment at MSKCC. ”The SpectraCure system is user-friendly,” said Doctor James A. Eastham. “Anyone familiar with transperineal prostate biopsy or prostate brachytherapy will be comfortable with the device. Overall, technically very simple and fortunately well-tolerated by the patient. Looking forward to using the SpectraCure system soon.”
“It is very encouraging that the new system was well-received by Dr. Eastham and his team at MSKCC, and equally encouraging that the first patient treated with the system is well,” says Johannes Swartling, CTO at SpectraCure. “The main goal of the clinical trial is, of course, to evaluate the medical aspects of the treatment, but evaluating the usability of the system is also required, and this is an important step in this work.”
For further information:
SpectraCure is developing a treatment system for the elimination of internal solid cancer tumors. We are initially focusing on recurrent prostate cancer, hoping to treat other cancers such as primary prostate cancer, breast cancer, pancreatic cancer, and head and neck cancer in the future. The approach is based on a proprietary and patented treatment system, Q-PRO®, consisting of a hardware device and a laser unit, which performs PDT treatment and treats the prostate itself, combined with a software device, the patented IDOSE® dose planning platform. The method allows the laser light dose to be controlled so that the tumour is exposed to an optimal dose to achieve sufficient treatment effect. The treatment system has the potential to make interstitial PDT treatment accurate, precise, safe for every patient. The goal is that in addition to being tumor free, the patient will be able to maintain their quality of life, with limited side effects. We are conducting clinical trials as an important part of the continued development of the company's treatment system. The company is listed in the Premier segment of the Nasdaq First North Growth Market with G&W Fondkommission as Certified Adviser, and trades under the short name SPEC.

Positive feedback from treatment with SpectraCure’s system Q-PRO® in New York

SpectraCure
Wed, Dec 07, 2022 11:00 CET
SpectraCure aims at becoming the Market Authorization Holder of the photosensitizing drug used together with the Q-PRO system. SpectraCure has now signed a Letter of Intent with German pharma company Cheplapharm to secure global supply of the required active product ingredient (API). SpectraCure has taken the strategic decision to become the Market Authorization Holder of the photosensitizing drug used as a part of the photodynamic therapy (PDT). This means that SpectraCure not only will sell the treatment platform Q-PRO, but also will, under its own trademark, market and sell the drug required to carry out the treatment. SpectraCure aims to register and thereby legally own the new drug which gives full control over the commercialization and pricing. The Letter of Intent signed between SpectraCure AB and Cheplapharm Arzneimittel GmbH is the basis of a strategic alliance for the global exclusive product supply from Cheplapharm to SpectraCure AB for the use in PDT treatment of prostate cancer. This cooperation is scheduled to be rolled out in the coming years. “This is very important for SpectraCure, both strategically and commercially. We see interesting opportunities to bundle the delivery of the drug and the consumables required for our treatment and thereby, in addition to revenues from the Q-PRO platform itself, also build revenue streams from the drug”, comments Johan Folkunger, CEO SpectraCure. This information is information that SpectraCure is obliged to make public according to the EU Market Abuse Regulation (EU No. 596/2014). The information was submitted, through the provision of the specified contact person, for publication on December 7, 2022, at 11:00 a.m.
For further information:
SpectraCure is developing a treatment system for the elimination of internal solid cancer tumours. We focus initially on recurrent prostate cancer treatment, with an aim for the future to also be able to treat other forms of cancer, such as primary prostate cancer, breast and pancreatic cancer, as well as tumours in the head and neck region. The method is based on the Company's proprietary and patented treatment system consisting of hardware, a laser unit which carries out PDT treatment and treats the prostate itself in combination with the software, the patented software dose planning platform IDOSE®. The method makes it possible to focus the laser to expose the tumour for the optimal dose to achieve sufficient effect of the treatment. The treatment method has the potential to make interstitial PDT treatment accurate, precise and safe for each patient. The objective is that the patient besides having the tumour removed shall be able to retain the quality of life, with limited side effects. We are conducting clinical trials as an important step in the continued development of the Company's treatment system. The share is traded on Nasdaq First North Premier Growth Market under the ticker SPEC. G&W Fondkommission is the Certified Adviser of the company, e-mail:  ca@gwkapital.se , telephone: +46(0) 8-503 000 50. Tags:

SpectraCures signs Letter of Intent with Cheplapharm

11/17
11/23/2022 | 08:26am EST
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SpectraCure is developing a medical device for the treatment of recurrent prostate cancer. It is a focal therapy that can be adapted to each patient's specific needs. SpectraCure is currently running a clinical study in the UK, US, and Canada, and the company has now signed an agreement with Skåne University Hospital in Malmö. The agreement covers participation in the clinical study, which will be initiated once approvals from the Swedish Medicines Agency and the Ethics Committee have been obtained. The study will include patients who have been diagnosed with recurrent prostate cancer after having previously undergone radiation therapy. The investigator responsible for the study is Anders Bjartell, professor and senior physician at Skåne University Hospital. The co-investigator is Ymir Saemundsson, urologist at Skåne University Hospital. "We look forward to participating in the study and start recruiting patients. In the future, we hope that SpectraCure's treatment will be an effective treatment option for patients who have been diagnosed with recurrent prostate cancer", says Anders Bjartell. The recruitment and treatment of patients will take place in parallel at all sites; Skåne University Hospital in Malmö, Princess Margaret Cancer Centre in Toronto, University College London Hospital, and at Memorial Sloan Kettering Cancer Center in New York. SpectraCure is currently having dialogues with additional hospitals that may be added to the study. The goal of the study is to show that the interstitial PDT treatment with SpectraCure's Q-PRO® system and the light-activated drug verteporfin is a safe and effective treatment for recurrent prostate cancer. "We are extremely pleased that we now have a collaboration and an agreement in place with Skåne University Hospital and we look forward to start treating patients as soon as we have received the regulatory approvals. Adding the hospital to the study will increase the pace of the clinical trial. Additionally, it is very valuable to co-operate with a hospital nearby", says SpectraCure's CEO Johan Folkunger. Skåne University Hospital: Skåne University Hospital provides emergency care as well as specialised healthcare in both Lund and Malmö. The hospital is the third largest university hospital in Sweden and has three main missions: advanced healthcare, research, and education. Skåne University Hospital is part of the Skåne University Hospital Comprehensive Cancer Centre (SUHCCC) whose goal is to conduct cancer care and cancer research of the highest international quality based on the patient's needs, with research-based treatment methods and innovations. Every year, more than 10,000 patients are cared for within the centre. For further information:

SpectraCure : Skåne University Hospital in Malmö is included in the clinical trial for treatment of recurrent prostate cancer

Publicerad 2020-06-26
First North-noterade forskningsbolaget Spectracure meddelar att bolagets företrädesemission har blivit fulltecknad. Detta innebär att bolaget tillförs cirka 140 miljoner kronor före transaktionskostnader. Det framgår av ett pressmeddelande. Emissionen tecknas till 5,5 procent av garantiåtaganden och till 17,5 procent av investerare i enlighet med garantiåtaganden. Emissionen var fullt garanterad och medför att det totala antalet aktier ökar med omkring 10 procent. – Nettolikviden från den genomförda emissionen ger Spectracure de finansiella resurser som krävs för att finansiera förberedelser och genomförande av en klinisk fas 3-studie, regulatoriska förberedelser inför FDA ansökan avseende accelererated approval, samt initiering av nya kliniska indikationer, säger vd Masoud Khayyami, i en kommentar. DELA DEN HÄR ARTIKELN

Spectracure stänger fulltecknad företrädesemission

| Source: Nasdaq Nordic
Stockholm, December 4, 2018— Nasdaq (Nasdaq: NDAQ) announces that the trading in SpectraCure AB’s shares (short name: SPEC) will commence today on Nasdaq First North in Stockholm. SpectraCure belongs to the health care sector and is the 76th company to be admitted to trading on Nasdaq’s Nordic markets* in 2018. SpectraCure is focused on cancer treatment with medical systems with laser light sources and photoreactive drugs - photodynamic therapy (PDT). The treatment method is suitable for internal solid tumours of various kinds, such as prostate, pancreas, and head and neck cancer. SpectraCure is a start-up company from Lund University, founded in 2003 and headquartered in Lund, Sweden. For more information, please visit www.spectracure.se . “The change of listing is expected to strengthen awareness of SpectraCure and attract a broader group of investors, as well as to give the company better access to both Swedish and international capital markets,” said Masoud Khayyami, CEO of SpectraCure. ”We welcome SpectraCure to Nasdaq First North,” said Adam Kostyál, SVP and Head of European Listings, Nasdaq. “SpectraCure joins our growing health care sector, and we look forward to supporting the company with the increased visibility that comes with a Nasdaq First North listing.”
SpectraCure AB has appointed G&W Fondkommission AB as the Certified Adviser. *Main markets and Nasdaq First North at Nasdaq Copenhagen, Nasdaq Helsinki, Nasdaq Iceland and Nasdaq Stockholm. About Nasdaq First North
Nasdaq First North is regulated as a multilateral trading facility, operated by the different exchanges within Nasdaq Nordic (Nasdaq First North Denmark is regulated as an alternative marketplace). It does not have the legal status as an EU-regulated market. Companies at Nasdaq First North are subject to the rules of Nasdaq First North and not the legal requirements for admission to trading on a regulated market. The risk in such an investment may be higher than on the main market. About Nasdaq
Nasdaq (Nasdaq: NDAQ) is a leading global provider of trading, clearing, exchange technology, listing, information and public company services. Through its diverse portfolio of solutions, Nasdaq enables customers to plan, optimize and execute their business vision with confidence, using proven technologies that provide transparency and insight for navigating today's global capital markets. As the creator of the world's first electronic stock market, its technology powers more than 100 marketplaces in 50 countries, and 1 in 10 of the world's securities transactions. Nasdaq is home to over 4,000 total listings with a market value of approximately $15 trillion. To learn more, visit business.nasdaq.com . Nasdaq Copenhagen, Nasdaq Helsinki, Nasdaq Iceland, Nasdaq Riga, Nasdaq Stockholm, Nasdaq Tallinn, Nasdaq Vilnius, Nasdaq Clearing and Nasdaq Broker Services are respectively brand names for the regulated markets of Nasdaq Copenhagen A/S, Nasdaq Helsinki Ltd., Nasdaq Iceland hf., Nasdaq Riga, AS, Nasdaq Stockholm AB, Nasdaq Tallinn AS, AB Nasdaq Vilnius, Nasdaq Clearing AB and Nasdaq Broker Services AB. Nasdaq Nordic represents the common offering by Nasdaq Copenhagen, Nasdaq Helsinki, Nasdaq Iceland and Nasdaq Stockholm. Nasdaq Baltic represents the common offering by Nasdaq Tallinn, Nasdaq Riga and Nasdaq Vilnius. Cautionary Note Regarding Forward-Looking Statements
The matters described herein contain forward-looking statements that are made under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about Nasdaq and its products and offerings. We caution that these statements are not guarantees of future performance. Actual results may differ materially from those expressed or implied in the forward-looking statements. Forward-looking statements involve a number of risks, uncertainties or other factors beyond Nasdaq's control. These factors include, but are not limited to factors detailed in Nasdaq's annual report on Form 10-K, and periodic reports filed with the U.S. Securities and Exchange Commission. We undertake no obligation to release any revisions to any forward-looking statements. Media Relations Contact:

Nasdaq Stockholm Welcomes SpectraCure to First North

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Companies developing medical devices (per the IMDRF's definition of "medical device"). Includes software, lab-developed tests (LDTs), and combination products. *Columns updated as regularly as possible.

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SpectraCure focuses on cancer treatments using medical systems with laser light sources and reactive drugs, which are referred to as "Interstitial Photodynamic Therapy", PDT, a treatment methodology suitable for internal solid tumours of various kind, e.g. prostate and abdominal salivary glands, but also other indications such as cancer of the head and neck.

Name	Work History	Title	Status
Henrik Ljung	Acconeer	Chief Financial Officer	Current
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