business plan july 2012 neolaser - ent july...

23
neoLaser - ENT July 2017

Upload: others

Post on 28-Jul-2020

10 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

Business Plan July 2012neoLaser - ENTJuly 2017

Page 2: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

• Private company• Headquarters and R&D in Israel• Founded in 2012• 2013-2014, 2014-2015, 2015-2016 CAGR 50-60%• > 30 distribution partners globally in North America, Europe, Asia,

Pacific and South/Central America regions• Key areas of activity – EVLA, Colorectal, Spine, ENT• Laser manufacturing in dedicated GMP compliant facility in Israel• Fiber manufacturing in Germany

The Company

neoLaser designs and manufactures top quality laser devices for the medical field

Page 3: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

• Founded and managed by Mr. Gil Shapira, engineer and physicist, MIT graduate, over 15 years of experience in developing, building and managing surgical lasers for multiple specialties. Previously VP Product Development and VP Marketing for OmniGuide, a Boston based MIT high growth surgical laser company

• Management team with over 50 years of combined specific domain experience in high end surgical lasers– Mrs. Dorit Rabkin, Quality and Regulatory Affairs, Lumenis

(Nasdaq LMNS), Yokneam Israel– Mrs. Galit Levite, Finance and Purchasing, Orsan, Israel– Mr. Gil Hadari, Manufacturing, OmniGuide, Boston MA

The Company - Leadership

Page 4: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

… the company, cont.• GMP compliant manufacturing facilities

(Laser and Fibers)• ISO13485 quality system• CE certification for neoV platform and all

models• 2 FDA Clearances (K133006, K152722)

covering all indications• Partnership with Adler K152417 on fibers

Page 5: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

neoV System Deployment Global

Current install rate of 150 systems per year globally

Key Markets: Germany, Netherlands, Italy, Australia, Spain, USA

Page 6: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

• Precision

• Unique design

• Portability

• Quality

• Reliability

• Usability

• 810, 980, 1064, 1470

The neoV Laser

Page 7: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

Tissue Interaction

Low absorption in Water and BloodAlmost equal absorptionVersatile tissue interaction (contact/non-contact)

Specifications25Watts clean out of fiberRed aiming beam1-25W in 0.1W stepsPulses from 100usec to 30secSingle or Repeat Pulse

Key Advantages

Unique designPortabilityStrong power outputUsabilityVersatile and powerful office-based tool

Products: neoV980

Page 8: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

Overview

Otosclerosis, Septal deformation, polyps, cysts, tonsillectomy, DCR, pappiloma surgery, excision of cancerous lesions and many more are all ENT conditions/ procedures treated with Laser Microsurgery

Laser energy is used to vaporize, ablate and cut soft tissue with controlled lateral thermal injury capable of coagulating blood vessels.

The 980nm laser, with almost equal absorption by blood and water in tissue, provides a versatile tool for precision cutting and strong coagulation in one source.

Page 9: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

Tissue Absorption

Lower absorption in waterNon-contact = deep penetrationContact = carbonization of tip and low penetration

980 Diode Cut 7W, Contact CO2 Laser Cut 7W

Page 10: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

Otology - Otosclerosis

Otosclerosis is a fibrous osteodystrophy of the human otic capsule; abnormal bone growth in the inner ear causing hearing loss and possible damage to the hearing nerve.

Suggested causes include: Hereditary, infectious (Measles), traumatic. Most common in (but not limited to) Caucasian women in their 40s.

Page 11: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

Otology - Stapedotomy

Stapedotomy

When surgical approach is preferred, laser provides the best solution enabling micro surgery with minimal acoustic and mechanical trauma. The 980nm wavelength also offers controlled thermal damage.

Page 12: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

Otology - Treatment

The recommended settings provided in this manual are a general guide that does not replace the experience of the users, their knowledge of the procedure and what may be

required for each and every patient.

• For this delicate operation it is recommended to use a power of 2.5W-3W and pulse duration of 100-200ms at SP mode

• Stapedotomy is performed using a thin optical fiber (273µ core). In preparation for surgery “pre-blackening” (carbonization) of the fiber tip is required.

• ALWAYS – BLACK TIP + CONTACT

Page 13: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

• 980nm is safe and effective for stapes surgery

• General behavior similar to KTP (green laser) when applied in the same way (contact mode)

Otology - Clinical Data

Page 14: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

• 100 patient study at Causse Clinic with the neoV980 (Dr. Robert Vincent) completed

• Awaiting publication of long term follow up later this year

• Initial estimated success rate of 90% (in line with KTP)

• First tool of choice for Causse Clinic

Otology - Clinical Data Cont

Page 15: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

• Turbinate surgery / reduction

• Nasal and paranasal sinus surgery

• HHT treatment

• Polyps, cysts, mucoceles

Rhinology – Endonasal Surgery

Page 16: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

• Publications and white papers on turbinate reduction and HHT

• Advantages

– Precision surgery

– Control of bleeding

– Short recovery

– Visualization

– Possible surgery under local anesthesia (also in office)

Rhinology – Clinical Data

Page 17: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

• ~15W, CW

• Horizontal lines (from anterior section of turbinate to posterior section)

• 3-4 lines per turbinate

• Total of ~100Joules per turbinate

• No nasal packing needed

• Antibiotic ointment after application

• Patients should do saline wash 3 times a day for 3 weeks

Turbinate Surgery - Technique

Page 18: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

• HHT– Non contact application

– 12-16W, blanch lesion until coagulated

– Tolerated as in office procedure

– Can be easily repeated if needed

• Polyps– 16W, CW

– If very small polyp can be ablated in non contact mode

– If bigger, cut at base in contact mode

HHT and Polyps

Page 19: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

• Laser tonsillotomy in children (LTT)

• Laser-assisted Uvulopalatoplasty (LAUP) for snoring prevention

• Tumor resections

• Partial glossectomy

Oropharynx - Procedures

Page 20: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

• Use of Diode lasers in laryngeal surgery

– Granulomas, polyps, web, papilloma

– Glottic carcinoma

– Subglottic stenosis, lesions

Laryngeal Procedures

Page 21: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

• 980nm is a wavelength which may penetrate the eye and cause irreversible damage (due to lower water absorption)

• Just like KTP (green) it is more dangerous than CO2

• Requires safety goggles and special filter on the microscope

Safety Considerations

Page 22: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

Products

Product Code Description Comments

OF99003 CORONA OTO fiber, 2.6meters length, 273um core, Slim, polyimide coating, OD 330um, Sterile

Slim fiber for otology. Compatible with surgical hand piece

OF99005 CORONA ENT fiber, 2.6meters length, 360um core, Slim, polyimide coating, OD 420um, Sterile

Slim fiber for general ENT use. Compatible with surgical hand piece

HS99001 ENT hand pieceResterilizableFor CORONA OTO and ENT fibers

Luer lock ending, compatible with all size/shape cannulas

ZUXXXXX Stainless steel extension cannulas, Various lengths and shapes

Compatible with surgical hand piece

BG03017 Eye protection filter, Zeiss/Moeller800-1100nm, Permanent, clear view

Effective eye protection for surgical microscope

BG03018 Eye protection filter, Leica800-1100nm, Permanent, clear view

Effective eye protection for surgical microscope

Page 23: Business Plan July 2012 neoLaser - ENT July 2017abramed.pl/media/301/file/neolaser-essentials-ent-july-2017.pdf · 980 Diode Cut 7W, Contact CO2 Laser Cut 7W. Otology - Otosclerosis

Thank you

neoLaser7 HaEshel St.

Caesarea Industrial ParkISRAEL 38900

[email protected]