Letter to shareholders July 18,2014
Dear Solos Endoscopy, Inc. Shareholders,
I am very pleased to be able to communicate with our loyal shareholders
directly and to give you an update on our progress this year.
Solos Endoscopy, Inc. has been at the forefront of breakthrough medical
devices and technologies for the treatment and management of diseases for
over 25 years. The Company markets over 200 items to the endoscopic market
and is continuing the development of products that will enhance the ability of
medical professionals to perform minimally invasive surgical techniques.
Solos Endoscopy has received its ISO 13485:2003 Certification from TUV SUD
America. The Certification to ISO 13485:2003 will in turn allow Solos Endoscopy to
place the CE Mark on the majority of its endoscopic instruments including the
MammoView® devices. The Certification Body of TUV America has certified that
Solos Endoscopy has established and is maintaining a quality management
system that meets the requirements of the European Union and Canada. The
Certification came at the conclusion of a lengthy Audit with TUV SUD America in
2013. The Audit included a comprehensive review of the Solos Endoscopy's
Quality Manual and 28 Quality System Procedures for compliance with the
international quality system standard ISO 13485:2003, to the European Union's
Medical Device Directive (MDD 93/42/EEC) and to the Canadian Medical
Device Regulations (SOR/98-282).
Health Canada’s Medical Device Bureau (MDB) completed its evaluation of
Solos Endoscopy’s instruments and has classified its devices as Class II medical
devices. The Medical Device Bureau reviewed the MammoView® Dilator Set,
MammoView® Cytology Retrieval Kit, MammoView® Introducer Set, and the
Microendoscope Ductoscope. Solos Endoscopy needed to complete the
review to apply for Canada’s Medical Device License. The Company has
delayed the filing of its application while management has been evaluating its
multiple options for the Canadian market. The Company is currently working
with Spectrum Medical Market Consultants to act as its representative in
Canada for its endoscopic instruments including the MammoView® devices.
Solos Endoscopy experienced significant back orders during the first six months
of 2014 due to supply issues related to a component manufacturer. As a result of
the back orders, the Company’s cash flow and sales declined. We are pleased
to inform the shareholders that we have resolved the issues and have resumed
shipping to hospitals this past week. We expect sales and cash flow to improve
over the next 90 days. In the last six months, fifteen new hospitals have begun to
carry Solos Endoscopy instruments. This includes a select number of hospitals
who are now carrying the MammoView® product line.
Solos has several exciting new advances in product development that will
change the way minimally invasive procedures are utilized in the medical field in
order to treat and prevent disease. These products will allow the physician to
examine organs and tissues within the body without the need for intrusive
surgery. The Company is currently marketing its next generation breast
endoscopy system, the MammoView® system, for early breast cancer
detection.
Solos Endoscopy, as a public Company, continues to update its shareholders
through regular postings on www.otcmarkets.com and through Company press
releases. Solos Endoscopy posted a disclosure regarding a notice it received
from the Depository Trust Company (DTC) on November 25, 2013. Since that
time, Solos Endoscopy’s legal counsel has provided DTC several legal opinions
to confirm that each of the Subject Securities, including the Notice Securities,
were, at the date of deposit at DTC, eligible under the Rules and Procedures of
DTC to be deposited for the Services.
To learn more information about the Company and its products visit
www.solosendoscopy.com. I want to thank all our loyal shareholders and I look
forward to a successful 2014.
Dear Solos Endoscopy, Inc. Shareholders,
I am very pleased to be able to communicate with our loyal shareholders
directly and to give you an update on our progress this year.
Solos Endoscopy, Inc. has been at the forefront of breakthrough medical
devices and technologies for the treatment and management of diseases for
over 25 years. The Company markets over 200 items to the endoscopic market
and is continuing the development of products that will enhance the ability of
medical professionals to perform minimally invasive surgical techniques.
Solos Endoscopy has received its ISO 13485:2003 Certification from TUV SUD
America. The Certification to ISO 13485:2003 will in turn allow Solos Endoscopy to
place the CE Mark on the majority of its endoscopic instruments including the
MammoView® devices. The Certification Body of TUV America has certified that
Solos Endoscopy has established and is maintaining a quality management
system that meets the requirements of the European Union and Canada. The
Certification came at the conclusion of a lengthy Audit with TUV SUD America in
2013. The Audit included a comprehensive review of the Solos Endoscopy's
Quality Manual and 28 Quality System Procedures for compliance with the
international quality system standard ISO 13485:2003, to the European Union's
Medical Device Directive (MDD 93/42/EEC) and to the Canadian Medical
Device Regulations (SOR/98-282).
Health Canada’s Medical Device Bureau (MDB) completed its evaluation of
Solos Endoscopy’s instruments and has classified its devices as Class II medical
devices. The Medical Device Bureau reviewed the MammoView® Dilator Set,
MammoView® Cytology Retrieval Kit, MammoView® Introducer Set, and the
Microendoscope Ductoscope. Solos Endoscopy needed to complete the
review to apply for Canada’s Medical Device License. The Company has
delayed the filing of its application while management has been evaluating its
multiple options for the Canadian market. The Company is currently working
with Spectrum Medical Market Consultants to act as its representative in
Canada for its endoscopic instruments including the MammoView® devices.
Solos Endoscopy experienced significant back orders during the first six months
of 2014 due to supply issues related to a component manufacturer. As a result of
the back orders, the Company’s cash flow and sales declined. We are pleased
to inform the shareholders that we have resolved the issues and have resumed
shipping to hospitals this past week. We expect sales and cash flow to improve
over the next 90 days. In the last six months, fifteen new hospitals have begun to
carry Solos Endoscopy instruments. This includes a select number of hospitals
who are now carrying the MammoView® product line.
Solos has several exciting new advances in product development that will
change the way minimally invasive procedures are utilized in the medical field in
order to treat and prevent disease. These products will allow the physician to
examine organs and tissues within the body without the need for intrusive
surgery. The Company is currently marketing its next generation breast
endoscopy system, the MammoView® system, for early breast cancer
detection.
Solos Endoscopy, as a public Company, continues to update its shareholders
through regular postings on www.otcmarkets.com and through Company press
releases. Solos Endoscopy posted a disclosure regarding a notice it received
from the Depository Trust Company (DTC) on November 25, 2013. Since that
time, Solos Endoscopy’s legal counsel has provided DTC several legal opinions
to confirm that each of the Subject Securities, including the Notice Securities,
were, at the date of deposit at DTC, eligible under the Rules and Procedures of
DTC to be deposited for the Services.
To learn more information about the Company and its products visit
www.solosendoscopy.com. I want to thank all our loyal shareholders and I look
forward to a successful 2014.
