ALANX), Sweden, Dec. 4, 2023 /PRNewswire/ -- ALANX, Sweden, Dec. 4, 2023 /PRNewswire/ -- 
THE SECOND QUARTER OF 2023/24 (MAY - JULY)         
In the quarter under review, there were a number of significant events           
It will run from 1 MAY to 31 OCTOBER 2023/24 (6 months).           
Statement from the CEO
It has been an intense second quarter for us, with record sales, increased operating profit, and a number of other great achievements that will help us take our business to the next level.. It has been an exciting year for us as we have made important changes to our US organization, entered new markets, received a new reimbursement code for our Axor IITM communication device, and initiated a strategic review process to accelerate our growth.. It has been announced that the FDA has cleared a clinical study on below-knee amputations that will be fully funded by the US Department of Defense upon the end of the period. In total, we can see how years of strategic initiatives to build a profitable and growing business are beginning to pay off in the long run
In total, we can see how years of strategic initiatives to build a profitable and growing business are beginning to pay off in the long run
In the second quarter, the company reported strong financial results. The revenues of the second quarter were SEK 27.6 million, an increase of 36.2% compared to the corresponding quarter last year (32 percent in local currency). It has been estimated that the operating profit amounted to SEK 4.4 million, when excluding direct currency effects. This increase can be attributed both to the steep growth of sales as well as to an improved operating cost structure which contributed to the increase in operating profit.
There has been an increase in the number of surgeries performed in the US, along with strong momentum for Axor IITM. As a result of the increase in the number of surgeries performed in the US, Integrum's osseointegrated external prosthetic connection device Axor IITM has also contributed to the strong sales growth in the period.. In September, the company received a new reimbursement code for Axor IITM, which will help drive growth in the US in the coming years. It is with the introduction of the new reimbursement code that we mark the beginning of a more formalized reimbursement process for our prosthetics. I am convinced that a formalized process will allow prosthetists to apply for reimbursement and reduce the risk associated with using products without a dedicated code and that will significantly improve the services we offer to our customers.
I am convinced that a formalized process will allow prosthetists to apply for reimbursement and reduce the risk associated with using products without a dedicated code and that will significantly improve the services we offer to our customers.
In the past quarter, Integrum has restructured its sales and marketing department in order to focus entirely on executing growth in the US, resulting in sharpened team in the US. During the month of September we appointed Alex Winber as Vice President of Sales and Marketing, a very valuable addition to our team as well. We are very pleased that Alex has accepted to join the US leadership team as he is a highly experienced sales and marketing executive with an outstanding talent for recognizing business opportunities.
Our long-term goal is to set a new global standard in the care of amputees in the future, so every new market entry in the rest of the world is an important step in the right direction towards our long-term goal of establishing a new global standard. Integrum signed a distribution agreement for the Turkish market at the end of October, generating sales of 1 million in the Turkish market.A total of 3 million Swedish kronas. A significant impact of the earthquake that occurred earlier this year has been felt strongly by the Turkish orthopedic healthcare system and there is an urgent need for innovative solutions in the field of orthopedics.. As a result of the establishment in Turkey as well as other factors, the business segment Rest of the World is continuing to grow in a positive manner.. During the month of September, I was able to travel to Kyiv to train Ukrainian orthopedic surgeons in advanced amputee care and to support the development of trauma care in the country. Immediately following the surgical training sessions, a workshop on war-related amputee care was held. This workshop was attended by some of the world's most prominent specialists and was sponsored by a number of Ukrainian ministries.
Immediately following the surgical training sessions, a workshop on war-related amputee care was held. This workshop was attended by some of the world's most prominent specialists and was sponsored by a number of Ukrainian ministries.
This paves the way for new indications. Integrum plans to submit a Pre-Market Approval, PMA, Application for the use of OPRATM in transhumeral amputations after meeting with the US Food and Drug Administration, FDA, during the pre-submission meeting. In light of additional internal analysis and dialogue with the FDA, Integrum feels that existing data is sufficient to qualify for a PMA in the new indication, based on their internal analysis and conversations with the FDA.
A new clinical trial is crucial for the development of additional indications
As of now, the FDA has approved the start of a clinical study with the OPRATM Implant System to be carried out at the level of amputation below the knee. This study, which will involve up to 30 patients, will be fully funded by the US Department of Defense, and will be conducted by the Walter Reed National Military Medical Center in Bethesda, Maryland.. The OPRATM Implant Systems will be supplied to Walter Reed on a commercial basis, and once the study is complete, Integrum will be able to use the data in a future regulatory process for use by the FDA.. It is anticipated that the results will play a vital role in developing a Pre-Market Approval application for use in below-knee amputations and we are looking forward to the study being initiated in the near future
It is anticipated that the results will play a vital role in developing a Pre-Market Approval application for use in below-knee amputations and we are looking forward to the study being initiated in the near future
The board of directors of Integrum has initiated an ongoing strategic review to ensure that the positive results we are now seeing both in business and operations are fully leveraged to boost future growth. A review and evaluation of strategic alternatives has been initiated in order to speed up the global roll-out of Integrum’s unique OPRATM Implant System.. There will be a strategic review of Integrum's implant systems to ensure that the global roll-out of Integrum's implant systems will be carried out with the highest efficiency possible, in the interest of both the patients as well as the shareholders.. While we are encouraged by the growth of our business over the past quarters, our focus is on what lies ahead for us. We are now at the point where all our previous efforts are beginning to pay off, and it is time to speed things up
We are now at the point where all our previous efforts are beginning to pay off, and it is time to speed things up
The 4th of December 2023, Mölndal
Rickard Brånemark's biography
Executive Vice President of the company
Here is a link to the interim report that can be found at:
http://integrum.se/investor-relations/financial-reports-calendar/for investors/
As a result of the EU Market Abuse Regulation (EU nr 596/2014) and the Swedish Securities Markets Act (2007:528), Integrum AB is required to make public the information contained in this disclosure. On Thursday, December 4, 2023, at 8:30 CET, the information was submitted to the media through the agency of the contact person for publication.
If you would like more information, please contact:
Rickard Brånemark, CEO. Phone: +46 70 846 10 61, E-mail: [email protected]
CFO: Jörgen Svanström. You can reach him by phone at +46 70 734 96 60, or by email at [email protected]
A Certified Adviser is:
It is the responsibility of Carnegie Investment Bank AB (publ) to act as the Company's Certified Adviser.
You can download the following files from the following links:
Integrum AB is the source of this information
Today, Integrum (publ) (Nasdaq First North Growth Market: INTEG B) announced that the company has held a pre-submission meeting with the US Food and Drug Administration in preparation for its application.
Previously, the press release did not include the appropriate MAR reference in the text for technical and administrative reasons, which we have now added. All other items have been updated as well...
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